Phase II Open-Label, Multi-Center Study of CP-547, 632, an Oral Tyrosine Kinase Inhibitor of VEGFR-2, in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube Cancer

OBJECTIVES:

Primary

• Determine the efficacy of CP-547,632, in terms of clinical response benefit (CA 125 response [complete response (CR) or partial response (PR)] or stable disease ≥ 16 weeks), in patients with recurrent or persistent small-volume ovarian epithelial, primary peritoneal serous, or fallopian tube cancer.

Secondary

• Determine progression-free survival of patients treated with this drug.
• Determine CA 125 response (CR or PR) rate in patients treated with this drug.
• Determine duration of CA 125 response in patients treated with this drug.
• Determine the safety of this drug in these patients.
• Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients.
• Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 in patients treated with this drug.
• Determine changes in the Hospital Anxiety and Depression Scale (HADS) in patients treated with this drug.