 - Serum creatinine 1.5 x IULN or a calculated or measured creatinine clearance 50 mLmin using the following formula: calculated creatinine clearance 140-age x wt weight kg x 0.85 if female72 x creatinine mgdl; these tests including creatinine mgdl if using calculated creatinine clearance must be obtained within 14 days prior to registration 