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

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

MedlinePlus related topics:

Cancer Ovarian Cancer

Drug Information available for:

Tyrosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

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
	Pfizer Investigational Site
	Quebec, Canada, G1R 2J6

Canada, Ontario
	Pfizer Investigational Site
	Hamilton, Ontario, Canada, L8V 5C2

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

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

Study placed in the following topic categories:

Ovarian cancer

Digestive System Neoplasms

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Ovarian epithelial cancer

Abdominal Neoplasms

Fallopian Tube Neoplasms

Recurrence

Fallopian Tube Diseases

Genital Diseases, Female

Digestive System Diseases

Peritoneal Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Fallopian tube cancer

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008

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