AzTrials
AzTrials

Fallopian Tube Clear Cell AdenocarcinomaPhase 3NCT00262847

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 3 study testing Bevacizumab, Carboplatin and Laboratory Biomarker Analysis in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 632 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Carboplatin and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,873 participants
Where
632 sitesin 4 countries
Study dates
Sep 2005to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; International Federation of Gynecology and Obstetrics (FIGO) stage III with any gross (macroscopic or palpable) residual disease or FIGO stage IV, defined surgically at the completion of initial abdominal surgery and with appropriate tissue available for histologic evaluation; the minimum surgery required was an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual; however, the surgeon is not required to have performed all of the items contained in this section of the GOG Surgical Procedures Manual; those patients with stage III cancer in which the largest maximal diameter of any residual tumor implant at the completion of this initial surgery is no greater than 1 cm will be defined as "optimal;" all others will be defined as "suboptimal;" measurable disease on post-operative imaging studies is not required for eligibility
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist or, if necessary, the Pathology Co-Chair, prior to entry; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/µl equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
  • Platelets greater than or equal to 100,000/µl; (CTCAE grade 0-1)
  • Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
  • Bilirubin less than or equal to 1.5 x ULN (CTCAE grade 1)
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  • Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)
  • Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
  • Patients with a GOG Performance Status of 0, 1, or 2
  • Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction
  • Patients with measurable and non-measurable disease are eligible; patients may or may not have cancer-related symptoms
  • Patients who have met the pre-entry requirements
  • An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian
  • Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not progestins for management of anorexia while on protocol directed therapy or prior to disease progression

Who cannot join

  • Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage Ia or Ib low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded
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  • Patients with acute hepatitis or active infection that requires parenteral antibiotics
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:
  • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
  • Myocardial infarction or unstable angina < 6 months prior to registration
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
  • CTCAE grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
  • History of CVA within six months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels [separate requests]; the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with or with anticipation of invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy (cycle 2)
  • Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
  • Core biopsy, within 7 days prior to the first date of bevacizumab/placebo therapy (cycle 2)
  • Patients with GOG Performance Grade of 3 or 4
  • Patients who are pregnant or nursing; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
  • Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the study chair or study co-chairs for uncertainty in this regard

Trial locations and contacts

632 sites in 4 countries.

318 sites in 4 countries

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium CCOP

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36202

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Georgia Regents University Medical Center

    Augusta, Georgia, 30912

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan St. Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Deaconess Medical Center

    Billings, Montana, 59107

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27216

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chattanooga Gynecological Oncology

    Chattanooga, Tennessee, 37403

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Memorial Hospital at Easton - Shore Regional Cancer Center

    Easton, Maryland, 21601

  • The Memorial Hospital at Easton

    Easton, Maryland, 21601

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Rocky Mountain Gynecologic Oncology PC

    Englewood, Colorado, 80110

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Kaiser Permanente - Fair Oaks Medical Center

    Fairfax, Virginia, 22033

  • Northbay Cancer Center

    Fairfield, California, 94533

  • Highlands Oncology Group PA - Fayetteville

    Fayetteville, Arkansas, 72703

  • Washington Regional Medical Center - Fayetteville

    Fayetteville, Arkansas, 72703

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33905

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Cancer Care Associates of Fresno Medical Group Inc

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Jude Medical Center

    Fullerton, California, 92835

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Spectrum Health-Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Gynecologic Oncology of West Michigan PLLC

    Grand Rapids, Michigan, 49546

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311-6519

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Hackensack University Medical CCOP

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Northern New Jersey CCOP

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Oncare Hawaii Inc-Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • Saint Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Capital Regional Medical Center

    Jefferson City, Missouri, 65101

  • East Tennessee State University

    Johnson City, Tennessee, 37614-0054

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Associates in Oncology Hematology PC -Kensington

    Kensington, Maryland, 20895

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Rappahannock General Hospital

    Kilmarnock, Virginia, 22482

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Knoxville Gynecologic Cancer Specialists PC

    Knoxville, Tennessee, 37920

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Long Beach Memorial Medical Center-Todd Cancer Institute

    Long Beach, California, 90806

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

Japan10 sites

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 890-8760

  • National Hospital Organization-Kobe Medical Center

    Kobe, 654-0155

  • Kure National Hospital

    Kure, Hiroshima, 737

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • Iwate Medical University School of Medicine

    Morioka, Iwate, 020-8505

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Tohoku University School of Medicine

    Sendai, Aoba-ku, 980-8574

  • Keio University

    Shinjuku-ku, Tokyo, 160-8582

  • National Cancer Center Hospital

    Tokyo, 104 0045

  • Tottori University

    Tottori, 680-8550

Other trials in Japan

South Korea7 sites

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Seoul National University Hospital

    Seoul, 110-744

  • Yongdong Severence Hospital

    Seoul, 135-720

  • Asan Medical Center

    Seoul, 138-736

  • Korea Cancer Center Hospital

    Seoul, 139-706

  • Ajou University Hospital

    Suwon, 443-721

  • Kangnam Sacred Heart Hospital

    Youngdungpo-gu, 150-071

Other trials in South Korea

Canada1 site

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm II) increases the duration of progression-free survival (PFS) when compared to 6 cycles of standard therapy alone (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of 5 concurrent cycles of bevacizumab plus extended bevacizumab for 16 cycles beyond the 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm III) increases progression-free survival when compared to 6 cycles of standard therapy (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

SECONDARY OBJECTIVES:

  1. In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with respect to progression-free survival, to determine whether the Arm III regimen prolongs progression-free survival when compared to the Arm II regimen.

II. To determine whether the Arm II or Arm III regimen increases the duration of overall survival when compared with the Arm I regimen.

III. To compare each of the experimental regimens to the Arm I regimen with respect to the incidence of severe toxicities or serious adverse events.

IV. To determine the impact on Quality of Life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O] trial outcome index [TOI]) following treatment with the above regimens.

TERTIARY OBJECTIVES:

  1. To assess the relationship between angiogenic markers and clinical outcome including tumor response, progression-free survival and overall survival in patients randomized to standard cytotoxic chemotherapy (paclitaxel and carboplatin) without bevacizumab, with concurrent bevacizumab or with extended bevacizumab.

II. To assess the predictive value of a set of genes whose expression correlates with survival of patients with stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

III. To bank whole blood for research. IV. To determine if genetic variations in genes associated with essential hypertension including WNK lysine deficient protein kinase 1 (WNK1), G protein-coupled receptor kinase 4 (GRK4) and kallikrein B (KLKB1) predict which patients are likely to develop bevacizumab-induced hypertension.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
Bevacizumab, Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Placebo
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT00262847
Study groupRoleWhat they receive
Arm I (placebo, paclitaxel, carboplatin)Active comparatorPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Placebo; Other: Quality-of-Life Assessment
Arm II (placebo, paclitaxel, carboplatin, bevacizumab)ExperimentalPatients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Placebo; Other: Quality-of-Life Assessment
Arm III (paclitaxel, carboplatin, bevacizumab)ExperimentalPatients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).

    Measured: From study entry until first disease progression, death or date of last contact, up to 6 years

Secondary outcomes (3)

  1. Overall Survival

    Median overall survival (OS)

    Measured: From study entry to death or last contact, up to 6 years

  2. Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0

    Eligible and Evaluable patients

    Measured: Up to 5 years

  3. Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)

    Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.

    Measured: At baseline, 9, 18, 36, 60, and 84 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2010
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262847
Sponsor's protocol ID
NCI-2009-00590
Other IDs
NCI-2009-00590, CDR0000455114, GOG-0218, GOG-0218, U10CA180868, U10CA027469
Status last verified
Jul 2019
First submitted
6 Dec 2005
Last updated
23 Jul 2019
Data monitoring committee
Yes

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • You B, Purdy C, Copeland LJ, Swisher EM, Bookman MA, Fleming G, Coleman R, Randall LM, Tewari KS, Monk BJ, Mannel RS, Walker JL, Cappuccini F, Cohn D, Muzaffar M, Mutch D, Wahner-Hendrickson A, Martin L, Colomban O, Burger RA. Identification of Patients With Ovarian Cancer Experiencing the Highest Benefit From Bevacizumab in the First-Line Setting on the Basis of Their Tumor-Intrinsic Chemosensitivity (KELIM): The GOG-0218 Validation Study. J Clin Oncol. 2022 Dec 1;40(34):3965-3974. doi: 10.1200/JCO.22.01207. Epub 2022 Oct 17.

    PubMed 36252167

  • Morgan RD, Ferreras C, Peset I, Avizienyte E, Renehan AG, Edmondson RJ, Murphy AD, Nicum S, Van Brussel T, Clamp AR, Lambrechts D, Zhou C, Jayson GC. c-MET/VEGFR-2 co-localisation impacts on survival following bevacizumab therapy in epithelial ovarian cancer: an exploratory biomarker study of the phase 3 ICON7 trial. BMC Med. 2022 Feb 11;20(1):59. doi: 10.1186/s12916-022-02270-y.

    PubMed 35144591

  • Tewari KS, Burger RA, Enserro D, Norquist BM, Swisher EM, Brady MF, Bookman MA, Fleming GF, Huang H, Homesley HD, Fowler JM, Greer BE, Boente M, Liang SX, Ye C, Bais C, Randall LM, Chan JK, Ferriss JS, Coleman RL, Aghajanian C, Herzog TJ, DiSaia PJ, Copeland LJ, Mannel RS, Birrer MJ, Monk BJ. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. J Clin Oncol. 2019 Sep 10;37(26):2317-2328. doi: 10.1200/JCO.19.01009. Epub 2019 Jun 19.

    PubMed 31216226

  • Eskander RN, Kauderer J, Tewari KS, Mannel RS, Bristow RE, O'Malley DM, Rubin SC, Glaser GE, Hamilton CA, Fujiwara K, Huh WK, Ueland F, Stephan JM, Burger RA. Correlation between Surgeon's assessment and radiographic evaluation of residual disease in women with advanced stage ovarian cancer reported to have undergone optimal surgical cytoreduction: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2018 Jun;149(3):525-530. doi: 10.1016/j.ygyno.2018.03.043. Epub 2018 Mar 15.

    PubMed 29550184

  • Tewari KS, Java JJ, Eskander RN, Monk BJ, Burger RA. Early initiation of chemotherapy following complete resection of advanced ovarian cancer associated with improved survival: NRG Oncology/Gynecologic Oncology Group study. Ann Oncol. 2016 Jan;27(1):114-21. doi: 10.1093/annonc/mdv500. Epub 2015 Oct 20.

    PubMed 26487588

  • Monk BJ, Huang HQ, Burger RA, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Liang SX, Wenzel L. Patient reported outcomes of a randomized, placebo-controlled trial of bevacizumab in the front-line treatment of ovarian cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2013 Mar;128(3):573-8. doi: 10.1016/j.ygyno.2012.11.038. Epub 2012 Dec 4.

    PubMed 23219660

  • Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX; Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2473-83. doi: 10.1056/NEJMoa1104390.

    PubMed 22204724

  • Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

    PubMed 21941283

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Carboplatin and Laboratory Biomarker Analysis in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by National Cancer Institute (NCI) at 632 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 632 sites in United States, Japan, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: From study entry until first disease progression, death or date of last contact, up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262847, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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