NCT00096239

CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Detailed description

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. OUTLINE: This is an open-label, multicenter study. Patients receive oral CP-547,632 once daily on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1 year.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	CP-547,632

Timeline

• Start date: 2004-12-01
• Completion: 2005-02-01
• First posted: 2004-11-09
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States