A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Primary Peritoneal Cavity Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Progression-free Survival at 6 Months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. 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
PRIMARY OBJECTIVES: I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug. IV. Determine the frequency of clinical response in patients treated with this drug. V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients. VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- •Recurrent or persistent after initial standard surgery or chemotherapy
- •Incurable with standard surgery, chemotherapy, or radiotherapy
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Outside the area of prior radiotherapy
- •Accessible to guided core needle biopsy
- •Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
- •May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free Survival at 6 Months
Time Frame: Every other cycle for 6 months.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Tumor Response
Time Frame: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.
Secondary Outcomes
- Overall Survival(From study entry to death or last contact, up to 5 years.)
- Duration of Progression-free Survival(Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.)