Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
Bevacizumab
+ Cyclophosphamide
+ Laboratory Biomarker Analysis
Carcinoma, Ovarian Epithelial+19
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location