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Bevacizumab, Radiation Therap...

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

Last Updated: 2018-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-11

Study Completion Date

2016-12-15

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

Conditions

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Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage IB Cervical Cancer AJCC v6 and v7 Stage IIA Cervical Cancer AJCC v7 Stage IIB Cervical Cancer AJCC v6 and v7 Stage III Cervical Cancer AJCC v6 and v7

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (radiation therapy, bevacizumab, cisplatin)

Patients 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.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type BIOLOGICAL

Given IV

Cisplatin

Intervention Type DRUG

Given IV

External Beam Radiation Therapy

Intervention Type RADIATION

Undergo EBRT

Internal Radiation Therapy

Intervention Type RADIATION

Undergo brachytherapy

Interventions

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Bevacizumab

Given IV

Intervention Type BIOLOGICAL

Cisplatin

Given IV

Intervention Type DRUG

External Beam Radiation Therapy

Undergo EBRT

Intervention Type RADIATION

Internal Radiation Therapy

Undergo brachytherapy

Intervention Type RADIATION

Other Intervention Names

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Anti-VEGF Anti-VEGF Humanized Monoclonal Antibody Anti-VEGF rhuMAb Avastin Bevacizumab Biosimilar BEVZ92 Bevacizumab Biosimilar BI 695502 Bevacizumab Biosimilar CBT 124 Bevacizumab Biosimilar FKB238 BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer Recombinant Humanized Anti-VEGF Monoclonal Antibody rhuMab-VEGF Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Definitive Radiation Therapy EBRT External Beam Radiotherapy External Beam RT external radiation External Radiation Therapy external-beam radiation BRACHYTHERAPY internal radiation Internal Radiation Brachytherapy Radiation Brachytherapy

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracey Schefter

Role: PRINCIPAL_INVESTIGATOR

Radiation Therapy Oncology Group

Locations

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Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Integrated Community Oncology Network-Southside Cancer Center

Jacksonville, Florida, United States

Site Status

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, United States

Site Status

Baptist Medical Center South

Jacksonville, Florida, United States

Site Status

Integrated Community Oncology Network-Florida Cancer Center Beaches

Jacksonville Beach, Florida, United States

Site Status

21st Century Oncology-Orange Park

Orange Park, Florida, United States

Site Status

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Site Status

21st Century Oncology-Palatka

Palatka, Florida, United States

Site Status

Bay Medical Center

Panama City, Florida, United States

Site Status

Integrated Community Oncology Network-Flager Cancer Center

Saint Augustine, Florida, United States

Site Status

Grady Health System

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Northwest Community Hospital

Arlington Heights, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Franciscan St. James Health-Olympia Fields Campus

Olympia Fields, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Saint Vincent Anderson Regional Hospital/Cancer Center

Anderson, Indiana, United States

Site Status

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

Site Status

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Providence Medical Center

Kansas City, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, United States

Site Status

Saint Luke's South Hospital

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center-KCCC

Shawnee Mission, Kansas, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

Norton Suburban Hospital and Medical Campus

Louisville, Kentucky, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Cape Radiation Oncology

Cape Girardeau, Missouri, United States

Site Status