Ovarian Neoplasms Clinical Trial
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
Verified date | July 2006 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Pfizer Investigational Site | Hamilton | Ontario |
Canada | Pfizer Investigational Site | Quebec | |
United States | Pfizer Investigational Site | Baltimore | Maryland |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Given the outcome of the primary objective, analysis of secondary objectives were not formalized. |
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