Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan
- Determine the nature and degree of toxicity of gemcitabine and topotecan in patients
with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary
peritoneal cavity cancer.
- Determine the response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the duration of progression-free survival and overall survival of patients
treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1
and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond
documentation of CR.
Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3
Masking: Open Label, Primary Purpose: Treatment
Barbara A. Goff, MD
University of Washington
United States: Federal Government
|University of Washington School of Medicine||Seattle, Washington 98195|