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

NCT00074867CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Pfizer

Enrollment

29

Start Date

2003-10-01

Study Type

INTERVENTIONAL

Official Title

A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer

Interventions

CP-547632

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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 Outcomes

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

Locations

Pfizer Investigational Site, Los Angeles, United States

Pfizer Investigational Site, Santa Monica, United States

Pfizer Investigational Site, Baltimore, United States

Pfizer Investigational Site, Boston, United States

Pfizer Investigational Site, Boston, United States

Pfizer Investigational Site, Boston, United States

Pfizer Investigational Site, New York, United States

Pfizer Investigational Site, Hamilton, Canada

Pfizer Investigational Site, Québec, Canada

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