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

Tracking Information

First Received Date ^ICMJE

December 22, 2003

Last Updated Date

November 6, 2006

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00074867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms

Intervention ^ICMJE

Drug: CP-547,632

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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 â‰¥40 U/ml on two separate consecutive determinations made â‰¥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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00074867

Responsible Party

Study ID Numbers ^ICMJE

A3521003

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP