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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Peritonea

Brief 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 Summary:

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 mon
Sponsor: Jonsson Comprehensive Cancer Center

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2004
Date Started: December 2004
Date Completion:
Last Updated: December 18, 2013
Last Verified: February 2005