Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

Completed · Phase 2

Conditions studied: Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

In brief

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.

Key facts

Study ID

NCT00074867

Run by

Pfizer

People needed

29

Starts

2003-10-01

Expected to finish

2004-09-01

Last updated by the study team

2006-11-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-125.
• For the purpose of this study, elevated CA-125 is defined as a value of ≥40 U/ml on two separate consecutive determinations made ≥1 week apart.
• CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account.
• No definitive disease or clinical and findings of small volume disease (\£1cm by spiral CT or \£2cm by conventional CT or clinical exam).

You may not qualify if…

• No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide.
• No prior consolidation therapy with cytotoxic agents for ovarian cancer.
• Continuation of hormone replacement therapy is permitted.
• No requirement for concomitant anticoagulant therapy.
• Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.

Where it is running

• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Hamilton, Ontario, Canada
• Pfizer Investigational Site — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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