Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00025233
Brief Summary:
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
Detailed Description:
OBJECTIVES:
I. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug.
IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
V. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.
VI. Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.
Study:
NCT00025233
Study Brief:
Protocol Section:
NCT00025233