Status:
COMPLETED
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
Lead Sponsor:
Pfizer
Conditions:
Ovarian Neoplasms
Peritoneal Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00074867
Start Date
October 1 2003
End Date
September 1 2004
Last Update
November 7 2006
Active Locations (9)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90095
2
Pfizer Investigational Site
Santa Monica, California, United States, 90404
3
Pfizer Investigational Site
Baltimore, Maryland, United States, 21237
4
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114