A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma
OBJECTIVES:
Primary
- Compare stable disease and objective response in patients with metastatic or
unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or
without imatinib mesylate.
Secondary
- Evaluate the median survival, progression-free survival, and response rate in patients
treated with gemcitabine hydrochloride and imatinib mesylate.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha
protein expression in both tumor cells and associated endothelial cells using
immunohistochemistry staining of paraffin-embedded tissue.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by histology
(clear cell vs nonclear cell) and prior therapy (immunotherapy/chemotherapy vs targeted
agents).
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on
days 1-5 and 8-12. Treatment repeats every 21 days for up to 2 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving partial or complete
response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and
imatinib mesylate in the absence of disease progression or unacceptable toxicity. Patients
with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
- Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral
imatinib mesylate on days 1-5 and 8-12.
In both arms, treatment repeats every 21 days for at least 3 courses in the absence of
disease progression or unacceptable toxicity.
Available archived tumor tissue samples are obtained for immunohistochemical analysis to
quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein
expression.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Stable disease
No
Mark Stein, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Federal Government
CDR0000539400
NCT00323791
April 2006
August 2007
Name | Location |
---|---|
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |