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

This study has been completed.

First Received on December 22, 2003. Last Updated on November 6, 2006 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00074867

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms	Drug: CP-547,632	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Tyrosine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	29
Study Start Date:	October 2003
Estimated Study Completion Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074867

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10016
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Canada
Pfizer Investigational Site
Quebec, Canada, G1R 2J6

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00074867 History of Changes
Other Study ID Numbers:	A3521003
Study First Received:	December 22, 2003
Last Updated:	November 6, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases

Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on February 09, 2012