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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00369122

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2006-08-11

Expected to finish

2016-12-15

Last updated by the study team

2018-03-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• University of Colorado — Denver, Colorado, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Southside Cancer Center — Jacksonville, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Florida Cancer Center Beaches — Jacksonville Beach, Florida, United States
• 21st Century Oncology-Orange Park — Orange Park, Florida, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• 21st Century Oncology-Palatka — Palatka, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Integrated Community Oncology Network-Flager Cancer Center — Saint Augustine, Florida, United States
• Grady Health System — Atlanta, Georgia, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Northwest Community Hospital — Arlington Heights, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
• Franciscan St. James Health-Olympia Fields Campus — Olympia Fields, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Saint Vincent Anderson Regional Hospital/Cancer Center — Anderson, Indiana, United States
• Franciscan Saint Francis Health-Beech Grove — Beech Grove, Indiana, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Reid Health — Richmond, Indiana, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States

Full record on ClinicalTrials.gov

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