Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Completed · Phase 2

Conditions studied: Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Stage IV Ovarian Cancer

In brief

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 other parts of the body. 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.

Key facts

Study ID

NCT00072566

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2003-12-01

Expected to finish

2008-11-01

Last updated by the study team

2015-05-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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