Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms
Conditions
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.
Interventions
DRUGCP-547,632
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Given the outcome of the primary objective, analysis of secondary objectives were not formalized. | — |
Countries
Canada, United States
Outcome results
None listed