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Cervical AdenocarcinomaPhase 2NCT00369122

Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer

A Phase 2 study testing Bevacizumab, Cisplatin and External Beam Radiation Therapy in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 106 sites in 2 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 phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Bevacizumab, Cisplatin and External Beam Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
106 sitesin 2 countries
Study dates
11 Aug 2006to 15 Dec 2016
Phase
Phase 2
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix, meeting 1 of the following stage criteria:
  • Stage IIB-IIIB lymph nodes
  • Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm
  • No positive para-aortic lymph nodes
  • Zubrod performance status 0-2
  • WBC >= 3,000/mm^3
Show all 50Show fewer
  • Absolute granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • INR < 1.5
  • Total bilirubin =< 1.5 mg/dL
  • Serum creatinine =< 1.5 mg/dL
  • AST and ALT =< 2.5 times upper limit of normal (ULN)
  • Serum calcium =< 1.3 times ULN
  • Hemoglobin >= 10 g/dL (transfusion allowed)
  • Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • None of the following illnesses or conditions:
  • Medical illness preventing the use of full-dose chemotherapy
  • Evidence of bleeding diathesis or coagulopathy
  • Prior medical or psychiatric illness that would prevent informed consent or limit survival to < 6 months
  • History of aneurysms, cerebrovascular accident, or arteriovenous malformations
  • Active gastrointestinal (GI) ulcers, GI bleeding, or active inflammatory bowel disease
  • Serious, nonhealing wound, ulcer, or current healing fracture
  • History of any type of fistula or GI perforation
  • Intra-abdominal abscess within the past 6 months
  • No prior invasive malignancy (except nonmelanomatous skin cancer) unless disease free for >= 3 years
  • No significant traumatic injury within the past 28 days
  • No clinically significant cardiovascular disease, such as the following:
  • Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)
  • Myocardial infarction within the past 12 months
  • Unstable angina within the past 12 months
  • New York Heart Association class II-IV congestive heart failure
  • Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia)
  • Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months
  • Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known HIV
  • No prior organ transplant
  • No prior surgery for carcinoma of the cervix other than biopsy
  • No prior surgical debulking of pelvic or para-aortic nodes
  • No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding
  • No prior systemic chemotherapy
  • No major surgical procedure or open biopsy within the past 28 days or anticipation of need for major surgical procedure during the course of the study
  • No fine needle aspirations or core biopsies within the past 7 days
  • No concurrent major surgical procedure
  • No concurrent epoetin alfa or Hypericum perforatum (St. John's wort)
  • No concurrent intensity-modulated radiotherapy
  • No concurrent transvaginal irradiation to control bleeding

Who cannot join

None listed.

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

United States103 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • 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

  • Cape Radiation Oncology

    Cape Girardeau, Missouri, 63703

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • University of Colorado

    Denver, Colorado, 80217-3364

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network-Southside Cancer Center

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network-Florida Cancer Center Beaches

    Jacksonville Beach, Florida, 32250

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • 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

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Norton Suburban Hospital and Medical Campus

    Louisville, Kentucky, 40207

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Franciscan St. James Health-Olympia Fields Campus

    Olympia Fields, Illinois, 60461

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Bay Medical Center

    Panama City, Florida, 32401

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania, 19141

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Reid Health

    Richmond, Indiana, 47374

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Integrated Community Oncology Network-Flager Cancer Center

    Saint Augustine, Florida, 32086

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Wright-Patterson Medical Center

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Main Line Health NCORP

    Wynnewood, Pennsylvania, 19096

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

Canada3 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

Other trials in Canada

About this study

Official title: A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA

This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine treatment-related serious adverse-event rates and adverse-event rates within the first 90 days from treatment start in patients with previously untreated locally advanced carcinoma of the cervix treated with bevacizumab, cisplatin, and concurrent pelvic radiotherapy.

SECONDARY OBJECTIVES:

  1. Evaluate treatment-related serious adverse events and adverse events at any time.

II. Evaluate disease-free survival (local, regional, or distant failure, or death due to any cause).

III. Evaluate overall survival (death due to any cause). IV. Implement the image-based brachytherapy guidelines proposed by the Transatlantic Image-Guided Brachytherapy Working Group.

  1. Collect CT scan or MRI-based dosimetry of brachytherapy applications used during the course of treatment for later analysis of feasibility and consistency as well as dose/volume assessments of tumor control and complications.

OUTLINE: This is a multicenter study.

Patients undergo pelvic external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

After completion of study treatment, patients are followed periodically.

Being tested
Bevacizumab, Cisplatin, External Beam Radiation Therapy, Internal Radiation Therapy
Medical subject headings
Uterine Cervical 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

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT

    Undergo EBRT

  • Internal Radiation TherapyRadiation

    Also called BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

    Undergo brachytherapy

Study groups in NCT00369122
Study groupRoleWhat they receive
Treatment (radiation therapy, bevacizumab, cisplatin)ExperimentalPatients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Receives: Biological: Bevacizumab; Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Radiation: Internal Radiation Therapy

What is being measured

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

  1. Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.

    Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.

    Measured: From start of treatment to 90 days.

Secondary outcomes (3)

  1. Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.

    Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.

    Measured: From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.

  2. Disease-free Survival (Three-year Rate Reported)

    Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.

    Measured: From registration to 3 years

  3. Overall Survival (Three-year Rate Reported)

    Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From registration to 3 years

Timeline

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

  1. First posted29 Aug 2006 (estimated)
  2. Study start11 Aug 2006
  3. Primary completion4 Jun 2010
  4. Study completion15 Dec 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369122
Sponsor's protocol ID
NCI-2009-00722
Other IDs
NCI-2009-00722, CDR0000493005, RTOG 0417, RTOG-0417, U10CA021661
Status last verified
Feb 2018
First submitted
24 Aug 2006
Last updated
20 Mar 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Cisplatin and External Beam Radiation Therapy in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 106 sites in 2 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 50 inclusion and 0 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 May 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?

Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start. (time frame: From start of treatment to 90 days.). 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 NCT00369122.

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 20 Mar 2018.

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