Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00074867
First received: December 22, 2003
Last updated: November 6, 2006
Last verified: July 2006
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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 2 |
| 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:
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 ≥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.
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:
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 May 22, 2013