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

Phase 2

Completed

• Conditions: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms

• Registration Number: NCT00074867
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-12-22
• Study First Submitted QC: 2003-12-23
• Study First Posted: 2003-12-24
• Study Completion: 2004-09
• Status Verified: 2006-07
• Last Update Submitted: 2006-11-06
• Last Update Posted: 2006-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.

Secondary Outcome Measures

Name	Time	Method
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Quebec, Canada