Clinical trial NCT00074867: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-12-24
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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 (\&#163;1cm by spiral CT or \&#163;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.

Primary outcomes:
measure: 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 outcomes:
measure: Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: