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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.