CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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.
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: CP-547,632||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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 Peritoneal Serous Cancer, or Fallopian Tube Cancer|
|Study Start Date:||December 2004|
|Study Completion Date:||February 2005|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096239
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Mark D. Pegram, MD||Jonsson Comprehensive Cancer Center|