NCT00369122

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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. 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.

Detailed description

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

• 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

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
DRUG	Cisplatin	Given IV
RADIATION	External Beam Radiation Therapy	Undergo EBRT
RADIATION	Internal Radiation Therapy	Undergo brachytherapy

Timeline

• Start date: 2006-08-11
• Primary completion: 2010-06-04
• Completion: 2016-12-15
• First posted: 2006-08-29
• Last updated: 2018-03-20
• Results posted: 2013-05-17

Locations

106 sites across 2 countries: United States, Canada