Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Primary Peritoneal Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Median Time to Progression
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
- •Unidimensionally measurable disease
- •Previously irradiated indicator lesions must have progressed after radiotherapy
- •Received a platinum-containing regimen for primary disease
- •No more than 2 prior chemotherapy regimens for recurrent disease
- •Must have received prior platinum-based chemotherapy for recurrent disease if it has been \> 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed)
- •Rechallenge with the same platinum-based regimen is considered 1 prior regimen
- •No history or clinical evidence of CNS disease, including primary brain tumor
- •No brain metastases
- •Performance status - SWOG 0-2
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (bevacizumab, cyclophosphamide)
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.
Intervention: Bevacizumab
Treatment (bevacizumab, cyclophosphamide)
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.
Intervention: Cyclophosphamide
Treatment (bevacizumab, cyclophosphamide)
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.
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
Median Time to Progression
Time Frame: Up to 3 years
Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.
Secondary Outcomes
- Response Rate Based on the RECIST(Up to 3 years)
- Median Overall Survival(Time from first day of treatment to time of death due to any cause, assessed up to 3 years)