EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.

Histologically or cytologically confirmed RCC (clear cell or non-clear cell allowed, but collecting duct or medullary excluded) that is considered pathologically Intermediate High or Very High Risk (see Sect 4.0); No hx distant mets; microvascular invasion of renal vein ok as long as M0; Full resection incl all clinically + nodes w/neg margins & plans for pt to start study drug w/in 84 days after resection; Bilateral renal tumors ok provided both tumors fully resected & at least one tumor meets criteria Sect. 5.1-5.2; No evidence residual or met RCC on CT w/oral and IV contrast after nephrectomy and w/in 28 days prior to reg (pts w/ subcentimeter pulmonary nodules, by CT scan, that are non-specific and considered unlikely to represent metastatic dx are eligible); Offered specimen banking; No prior anti-cancer tx for RCC (except radical or partial nephrectomy noted above) incl systemic tx in adj or neo-adj setting, immunotherapy, investigational therapy, surgical metastastectomy or RT; No plans to receive other anti-cancer agents including investigational agents while on prot tx; Not rec'g chronic, systemic tx w/corticosteroids or other immunosuppressive agent; Topical or inhaled corticosteroids ok; No immunization w/attenuated live vaccine w/in 7 days prior to reg & no plans to receive while on prot tx;
Not taking, nor plan to take while on prot tx, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers; No Grade III/IV cardiac dx; No known uncontrolled underlying pulmonary dx, nor hypersensitivity to everolimus, other rapamycins or its excipients; PE/Med Hx, ANC >/= 1500, PLT >/= 100,000, HGB >/= 9, serum creatinine </= 2.0 ULN or calculated CrCl >/= 30, bili </= 1.5 ULN, SGOT & SGPT </= 2.5 ULN w/in 28 days prior to reg; No liver dx such as cirrhosis or severe hepatic impairment (Child-Pugh Class C); NOTE: a detailed assessment of Hep B/C medical hx and risk factors must be done at screening; No known hx HIV seropositivity; Fasting cholesterol, triglycerides and glucose w/in 28 days prior to reg; Able to take oral medications with no impairment of GI function or GI dx that may significantly alter absorption of drug; Zubrod PS 0 or 1; 18 yrs of age or older; No other prior malignancy (see 5.23); Not pregnant nor nursing & if of reproductive potential, has agreed to effective contraceptive method.