Phase II Clinical Trial Of Bevacizumab (IND 7,921; NSC 704865) And Low Dose Oral Cyclophosphamide In Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian
epithelial or primary peritoneal cancer treated with bevacizumab and low-dose
cyclophosphamide.
Secondary I. Determine the response rate in patients treated with this regimen. II.
Determine the toxicity of this regimen in these patients. III. Determine molecular
correlates for response and outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course
and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral
cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2
years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival defined according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Kaplan-Meier plots will be constructed. Cox proportional hazards model will be used.
6 months
No
Agustin Garcia
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2012-02562
NCT00072566
December 2003
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |