Completed

Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

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What is being tested

Bevacizumab

+ Cyclophosphamide

+ Laboratory Biomarker Analysis

BiologicalDrugOther
Who is being recruted

Carcinoma, Ovarian Epithelial+19

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma 
NCT00072566
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsPathologic ProcessesRecurrenceUrogenital NeoplasmsDisease AttributesFemale Urogenital Diseases

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study 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

Suspended

City of Hope Comprehensive Cancer Center

Duarte, United StatesSee the location
CompletedOne Study Center