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Phase II Study of Bevacizumab and Low-Dose Cyclophosphamide in Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II | Treatment | Completed | Not specified | CCC-PHII-45 CHNMC-PHII-45, NCI-5789, NCT00072566, 5789 |
Objectives Primary - Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.
Secondary - Determine the response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine molecular correlates for response and outcomes in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- 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
Prior/Concurrent Therapy:
Biologic therapy - No prior antiangiogenesis agents
Chemotherapy - See Disease Characteristics
- Recovered from prior chemotherapy
Endocrine therapy Radiotherapy - See Disease Characteristics
- Recovered from prior radiotherapy
Surgery - More than 28 days since prior major surgical procedure or open biopsy and recovered
Other - At least 3 weeks since prior therapy directed at the malignancy
- No recent or concurrent full-dose anticoagulants or thrombolytic agents
- Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed
- No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- No bleeding diathesis
- No coagulopathy
Hepatic - Bilirubin no greater than 1.5 times normal
- ALT or AST no greater than 3 times upper limit of normal
- INR less than 1.5 (for patients receiving warfarin)
Renal - Creatinine no greater than 1.5 times normal
- No proteinuria (less than 1+)
OR - Proteinuria less than 500 mg/24-hour urine collection
Cardiovascular - No prior deep vein thrombosis
- No prior stroke
- No clinically significant cardiovascular disease
- None of the following within the past year:
- Uncontrolled hypertension
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Grade II or greater peripheral vascular disease
- None of the following within the past 6 months:
- Unstable angina
- Myocardial infarction
- Transient ischemic attack
- Cerebrovascular accident
- Other arterial thromboembolic event
- No clinically significant peripheral artery disease
Immunologic - No active infection requiring parenteral antibiotics
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
Other - Not pregnant or nursing
- Fertile patients must use effective contraception
- No serious, non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No seizures not controlled with standard medical therapy
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- All prior invasive malignancies must be in complete remission
- No other concurrent medical, psychological, or social condition that would preclude study participation
Expected Enrollment A total of 23-55 patients will be accrued for this study within 1-2 years. 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. Published ResultsGarcia AA, Hirte H, Fleming G, et al.: Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia. J Clin Oncol 26 (1): 76-82, 2008.[PUBMED Abstract] Schultheis AM, Yang D, Garcia AA, et al.: Angiogenesis pathway gene polymorphisms associated with clinical outcome in recurrent ovarian cancer treated with low dose cyclophosphamide and bevacizumab: a California Consortium Trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-5017, 260s, 2006.
Trial Contact Information
Trial Lead Organizations California Cancer Consortium | | | Agustin Garcia, MD, Study coordinator(Contact information may not be current) | | | |
Registry Information | | Official Title | | Phase II Clinical Trial Of Bevacizumab (IND 7,921; NSC 704865) And Low Dose Oral Cyclophosphamide In Recurrent Ovarian Cancer Or Primary Peritoneal Carcinoma | | Trial Start Date | | 2003-12-31 | | Registered in ClinicalTrials.gov | | NCT00072566 | | Date Submitted to PDQ | | 2003-10-09 | | Information Last Verified | | 2005-05-04 | | NCI Grant/Contract Number | | P30-CA33572, N01-CM17101 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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