Status:
COMPLETED
Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Eligibility:
FEMALE
Phase:
PHASE2
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 ot...
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...
Eligibility Criteria
Inclusion
- 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
- At least 3 months
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No bleeding diathesis
- No coagulopathy
- 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)
- Creatinine no greater than 1.5 times normal
- No proteinuria (less than 1+)
- Proteinuria less than 500 mg/24-hour urine collection
- 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
- No active infection requiring parenteral antibiotics
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- 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
- No prior antiangiogenesis agents
- See Disease Characteristics
- Recovered from prior chemotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy and recovered
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00072566
Start Date
December 1 2003
End Date
November 1 2008
Last Update
May 12 2015
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010