A Phase II Study of Flavopiridol (NSC-649890) 1 Hour Bolus Days 1-3 Q 21 Days in Patients with Advanced Renal Cell Cancer

Pts must have histologically or cytologically conf renal cell carcinoma which is metastatic (M1). Pts w/unresectable primary tumor (but M0) are also eligible. Pts must have meas disease assessed w/in 28 days prior to reg. See Section 5.2 regarding soft tissue disease that has been radiated. Pts w/metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection. At least 28 days must have elapsed since surgery and pt must have recovered from any adverse effects of surgery. Pts may have rec'd one prior immunotherapy w/either IFN or IL-2 or a combination. At least 28 days must have elapsed since the last treatment and pt must have recovered from any adverse effects. Pts may have rec'd prior RT and at least 21 days must have elapsed and pt must have recovered from all associated toxicities. Pts must not have had prior chemo for renal cell cancer. Pts must have a Zubrod PS of 0-2. Because of the unknown side effects of flavopiridol, pregnant or nursing women may not participate. Women and men of reproductive potential must have agreed to use an effective contraceptive method. Pts w/a hx of brain mets or who currently have treated or untreated brain mets are not eligible. Pts w/clinical evidence of brain mets must have a brain CT or MRI negative for metastatic disease w/in 56 days prior to reg. Pts w/a hx of allergic reactions to similar compounds are not eligible. Pts w/any uncontrolled intercurrent illness are not eligible. Pts w/a known hypercoagulable state (other than the concurrent RCC) are ineligible. Pts w/out an identifiable hypercoagulable state but a hx of an isolated PE or DVT are eligible provided it occurred at least 6 mos prior to the date of reg. Pts must be offered participation on the correlative studies & w/consent, specimens should be submitted. No other prior malignancy is allowed expect as outlined in Section 5.14.