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

Primary Purpose

Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-547,632
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
December 22, 2003
Last Updated
November 6, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00074867
Brief Title
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-547,632
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 ≥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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3521003&StudyName=Study+Of+An+Oral+Tyrosine+Kinase+Inhibitor+Of+VEGFR%2D2+To+Treat+Small%2DVolume+Ovarian%2C+Peritoneal%2C+Fallopian+Tube+Cancer+
Description
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Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

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