Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
Part of paid clinical trials in Burbank, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00369122
- Phase
- PHASE2
- Status
- Completed
Conditions
- 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
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — BIOLOGICALGiven IV
- Cisplatin — DRUGGiven IV
- External Beam Radiation Therapy — RADIATIONUndergo EBRT
- Internal Radiation Therapy — RADIATIONUndergo brachytherapy
Study Details
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 Dates
- First listed
- Aug 29, 2006
- Start date
- Aug 11, 2006
- Status verified
- Feb 2018
- Primary completion
- Jun 4, 2010
- Completion
- Dec 15, 2016
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 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.
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. ]
Locations (103)
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