Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
- Determine response in patients with locally advanced unresectable or metastatic renal
cell carcinoma treated with gemcitabine and irinotecan.
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine median and progression-free survival in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes
on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease
progression or unacceptable toxicity. Patients receive 2 additional courses beyond best
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30
Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Uzair B. Chaudhary, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|