AzTrials
AzTrials

Endometrial AdenocarcinomaPhase 2NCT00977574

Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

A Phase 2 study testing Bevacizumab, Carboplatin and Ixabepilone in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 230 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Carboplatin and Ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
230 sitesUnited States
Study dates
14 Sep 2009to 6 Mar 2027
Phase
Phase 2

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 must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma
  • Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma
  • Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patients must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
  • Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1
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  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN), CTCAE v3.0 grade 1
  • Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
  • Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
  • Urine protein creatinine (UPC) ratio must be < 1.0 gram (gm); if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended (24-hour urine protein level must be < 1000 mg for patient enrollment)
  • UPC ratio of spot urine is an estimation of the 24 urine protein excretion
  • A UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 x ULN
  • Fasting cholesterol less than 300 mg/dL (CTCAE v3.0 grade 1)
  • Fasting triglycerides =< 2.5 x ULN (CTCAE v3.0 grade 1)
  • Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma
  • Patients must NOT have received prior therapy with bevacizumab or other VEGF pathway targeted therapy; patients must NOT have received prior therapy with temsirolimus, everolimus, ridaforolimus, sirolimus, or any other PI3K/ v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycins (mTor) pathway targeted therapy
  • Patients may have receive prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy; the prior radiation field, radiation dose, number of fractions and prior radiation start and stop dates must be provided on the Fast Fact Sheet (FFS) at registration
  • Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Who cannot join

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies as noted below, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years 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 within the last three years 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 with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal/pelvic fistula, gastrointestinal perforation or intra-abdominal abscess within 3 months prior to the first date of study therapy; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected
  • 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 or any brain metastases
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  • 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 within 6 months of the first date of study therapy
  • New York Heart Association (NYHA) class II or greater congestive heart failure
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
  • CTCAE grade 2 or greater peripheral vascular disease.
  • History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study therapy.
  • Aortic aneurysm and/or history of aortic dissection
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients undergoing invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab or temsirolimus therapy
  • Major surgical procedure anticipated during the course of the study.
  • Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of study therapy
  • Patients with known prior history of interstitial pneumonitis
  • Patients with CTCAE v. 3, grade 2 or greater hypoxemia
  • Patients with CTCAE v. 3, grade 2 or greater dyspnea
  • Patients must not have uncontrolled diabetes, and must not have baseline hemoglobin A1C (HgbA1C) > 8
  • Patients with peripheral neuropathy > CTCAE v.3, grade 1
  • Patients who are pregnant or nursing

Trial locations and contacts

230 sites in 1 country.

230 sites in 1 country

United States230 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • 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

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • PeaceHealth Medical Group PC

    Bellingham, Washington, 98226

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • 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, 27215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • 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

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • 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

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • South Carolina Oncology Associates PA

    Columbia, South Carolina, 29210

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • John Muir Medical Center-Concord

    Concord, California, 94520

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Rocky Mountain Gynecologic Oncology PC

    Englewood, Colorado, 80110

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • New York Hospital Medical Center of Queens

    Fresh Meadows, New York, 11365

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Hawaii Cancer Care Inc - Waterfront Plaza

    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

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Central Georgia Gynecologic Oncology

    Macon, Georgia, 31201

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Skagit Regional Health Cancer Care Center

    Mount Vernon, Washington, 98274

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Yale University

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Saint Luke's Hospital-Warren Campus

    Phillipsburg, New Jersey, 08865

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Center of Hope at Renown Medical Center

    Reno, Nevada, 89502

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24033

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • San Diego VA Medical Center

    San Diego, California, 92161

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • University of Washington Medical Center - Northwest

    Seattle, Washington, 98133

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Olympic Medical Cancer Care Center

    Sequim, Washington, 98384

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Saint Joseph Medical Center Hematology and Oncology - Silverdale

    Silverdale, Washington, 98383

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

    Spokane, Washington, 99204

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Overlook Hospital

    Summit, New Jersey, 07902

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Maui Memorial Medical Center

    Wailuku, Hawaii, 96793

  • Pacific Cancer Institute of Maui

    Wailuku, Hawaii, 96793

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center - Memorial Division

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC #704865), Paclitaxel/Carboplatin/Temsirolimus (NSC #683864) and Ixabepilone (NSC #710428)/Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the hazard of progression or death of each of the three arms relative to that of historical controls in patients with advanced or recurrent endometrial cancer.

SECONDARY OBJECTIVES:

  1. To determine the nature, frequency, and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 for each of the three arms.

II. To estimate the distribution of the duration of overall survival for each of the three arms.

III. To estimate the proportion of patients with measurable disease who have confirmed objective tumor responses by treatment.

TERTIARY OBJECTIVES:

  1. Explore the associations between select biomarkers and progression-free survival as well as secondary measures of clinical outcome (overall survival, tumor response, or disease status if possible) in the context of histologic cell type and treatment.

IA. Somatic mutations in phosphatase and tensin homolog (PTEN)/ phosphoinositide-3-kinase (PI3K) and RAS pathway members by Sequenom mutational profiling and targeted sequencing of candidate genes.

IB. Microsatellite instability by analysis of five National Cancer Institute consensus microsatellite markers (BAT25, BAT26, D2S2123, D5S346, and D17S250) using the Applied Biosystems (ABI) Prism 3100 Genetic Analyzer.

IC. Copy number alterations (gains or losses) by array comparative genomic hybridization (aCGH).

ID. Tumor expression of PTEN and class III beta-tubulin using immunohistochemistry.

IE. Concentration of vascular endothelial growth factor (VEGF) in pre-cycle 1 plasma using an enzyme-linked immunosorbent assay.

II. Explore the relationship among the various biomarkers by histologic subtype and treatment.

III. Explore which combination of biomarkers and clinical covariates optimally predicts responsiveness and resistance to the three treatment arms.

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

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over 30 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive bevacizumab beginning on course 2.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus* IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive temsirolimus beginning on course 2.

ARM III: Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients undergoing treatment post-surgery (=< 12 weeks) receive bevacizumab beginning on course 2.

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

Being tested
Bevacizumab, Carboplatin, Ixabepilone, Laboratory Biomarker Analysis, Paclitaxel

What participants receive

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

  • BevacizumabBiological

    Also called ABP 215, ABP-215, ABP215, Alymsys

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • IxabepiloneDrug

    Also called (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • TemsirolimusDrug

    Also called CCI 779, CCI-779, CCI-779 Rapamycin Analog, CCI779

    Given IV

Study groups in NCT00977574
Study groupRoleWhat they receive
Arm I (paclitaxel, carboplatin, bevacizumab)ExperimentalPatients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel
Arm II (paclitaxel, carboplatin, temsirolimus)ExperimentalPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Drug: Temsirolimus
Arm III (ixabepilone, carboplatin, bevacizumab)ExperimentalPatients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Drug: Ixabepilone; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Number of Participants Who Progressed or Died by 25 Months From Enrollment

    PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574

    Measured: at 25 months

Secondary outcomes (3)

  1. Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.

    Measured: Median of 10 cycles of treatment plus 30 days

  2. The Median Duration of Overall Survival for Each of the Three Arms.

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Measured: Time from date of study entry to time of death or the date of last contact, assessed up to 5 years

  3. The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.

    RECIST 1.1 was used to define objective tumor response. A complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A partial response is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. There can be no unequivocal progression of non-target lesions and no new lesions. Complete and partial responses are included in the objective tumor response rate. Confirmation of response was not required.

    Measured: Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 months

Timeline

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

  1. First posted15 Sep 2009 (estimated)
  2. Study start14 Sep 2009
  3. Primary completion31 Jan 2015
  4. Study completion6 Mar 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00977574
Sponsor's protocol ID
NCI-2011-01969
Other IDs
NCI-2011-01969, GOG-0086P, CDR0000654472, GOG-0086P, GOG-0086P, U10CA180868, U10CA027469
Status last verified
Sep 2026
First submitted
12 Sep 2009
Last updated
9 Sep 2026
Data monitoring committee
No

Publications

  • Thiel KW, Devor EJ, Filiaci VL, Mutch D, Moxley K, Alvarez Secord A, Tewari KS, McDonald ME, Mathews C, Cosgrove C, Dewdney S, Aghajanian C, Samuelson MI, Lankes HA, Soslow RA, Leslie KK. TP53 Sequencing and p53 Immunohistochemistry Predict Outcomes When Bevacizumab Is Added to Frontline Chemotherapy in Endometrial Cancer: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2022 Oct 1;40(28):3289-3300. doi: 10.1200/JCO.21.02506. Epub 2022 Jun 3.

    PubMed 35658479

  • Leslie KK, Filiaci VL, Mallen AR, Thiel KW, Devor EJ, Moxley K, Richardson D, Mutch D, Secord AA, Tewari KS, McDonald ME, Mathews C, Cosgrove C, Dewdney S, Casablanca Y, Jackson A, Rose PG, Zhou X, McHale M, Lankes H, Levine DA, Aghajanian C. Mutated p53 portends improvement in outcomes when bevacizumab is combined with chemotherapy in advanced/recurrent endometrial cancer: An NRG Oncology study. Gynecol Oncol. 2021 Apr;161(1):113-121. doi: 10.1016/j.ygyno.2021.01.025. Epub 2021 Feb 2.

    PubMed 33541735

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