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

NCT ID: NCT00074867

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-09-30

Brief Summary

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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

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Conditions

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Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CP-547,632

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Santa Monica, California, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Hamilton, Ontario, Canada

Site Status

Pfizer Investigational Site

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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A3521003

Identifier Type: -

Identifier Source: org_study_id