A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer

Pt must have histologic or cytologic confirmed RCC which is either M1 or unresectable. Pt must have MX disease. If pt has had surgery, 28 days must have lapsed and pt must have recovered from any adverse effects of surgery. Pt must not have rec'd any prior systemic therapy for
RCC including chemo, IFN, IL-2, other BRM, anti-angiogenic therapy, hormonal therapy or any other experimental systemic therapy. Prior thyroid medication is allowed. Pt may have rec'd prior RT to less than 25% of bone marrow, but 28 days must have lapsed since completion. W/in 28 days prior to reg, pts must have total bili </= IULN, SGOT or SGPT </= 2.5 x IULN and serum creatinine </= IULN or calculated CrCl >/= 60 mL/min for pts w/levels above IN. Pts who have had a prior nephrectomy must have a serum creatinine </= 2 x IULN. Pt must be offered opportunity to submit specimens. Pts must have PS 0-2. Pts w/hx of brain mets are not eligible. Ongoing systemic corticosteroid therapy is not permitted. Pts must not be on drugs known to be potent inhibitors of the CYP 3A4 enzyme (ketoconazole, itraconazole, ritonavir, products containing grapefruit juice, cyclosporine, carbamazepine, phenytoin, and phenobarbitol). Pts must be able to take oral meds w/out crushing, dissolving or chewing. Pts must not be pregnant, nor nursing and women/men of reproductive potential must agree to use an effective contraceptive method. No other prior malignancy is allowed.