Ovarian Cancer Clinical Trial
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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