A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients with Advanced Renal Cell Cancer

Pt must have histo or cyto confirmed RCC which is metastatic (M1). Pt w/unresectable primary tumor, but MO are eligible. Pt must have measurable disease assessed w/in 28 days prior to reg. Non-measurable disease must be assessed w/in 42 days prior to reg. Pt my have undergone resection, but 28 must have elapsed. Pt may have rec'd 1 or 2 prior immunotherapy regimens w/either IFN and/or IL-2 or the combo of IFN/IL-2 >28 days prior to reg. Pt may have rec'd prior RT to < 25% of bone marrow >21 days prior to reg. Pt must not have rec'd prior chemo for RCC. Pt must have AGC >/= 1,500; PLT >/= 100,000; CrCl >/= 50 ml/min; bili and SGOT </= 1.5 x IULN w/in 28 days prior to reg. Pt must have Zubrod PS 0-2. Pt must be offered participation in correlatives (see Sect 15). Pts w/hx of brain mets or who currently have brain mets are not eligible. Pt must not have any uncontrolled intercurrent illness. Pt must not be planning to receive the antiviral agent sorivudine or its chemically related analogues. It pt has rec'd, at least 4 wks must have elapsed since last dose.