RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced unresectable or metastatic kidney cancer.
OBJECTIVES: Primary * Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma treated with gemcitabine and irinotecan. Secondary * 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 response. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Response Proportion
Time frame: From registration until time of complete response or partial response
Duration of Response
Time frame: From registration until disease progression among patients who had at least a partial response
Number of Participants Who Experienced SAEs on Study
Time frame: From the day of first dose until the end of study, for an average of 6 months
Progression-free Survival
Time frame: Time between registration and disease progression or death, whichever comes first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.