A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU

Known locally adv, locally recurrent or met colorectal adenocarcinoma not curable by surgery or amenable to RT w/curative intent. PD following one prior 5-FU based regimen for met disease or failure during or w/in 6 mos of 5-FU based adj therapy. Histo or cyto conf adenocarcinoma of the colon or rectum (see Section 3.13). Meas or eval disease. Life expect > = 12 wks. ECOG PS 0-2. > = 4 wks from major surgery; > = 2 wks from minor surgery; > = 4 wks from major RT; > = 4 wks from prior chemo. Following labs obtained < = 14 days prior rand: ANC > =1500 mm3; PLT > = 100,000 mm3; HGB > = 9.0 gm/dL; creatinine < = 1.5 x UNL; bili < = 1.5 mg/dL; AST < = 5 x UNL; alk phos < = 5 x UNL. Pts of childbearing potential must agree to use eff meth of contraception. Able & willing to complete the QOL assessments in English. Pt must not have more than one prior chemo regimen for adv colorectal ca, prev CPT-11 or other camptothecin derivative; prev oxaliplatin, prior RT to > 25% of bone marrow; concurrent use of other inv chemo agents; active or uncontrolled infection; uncontrolled high blood pressure, unstable angina; symptomatic congestive heart failure; myocardial infarc < = 6 mos prior to rand; serious uncontrolled cardiac arrhythmia; NY Heart Assoc classification III or IV. Pt must not be pregnant or nursing. Pt must not have prior malignancy, known CNS mets or carcinomatous meningitis, interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung; pleural effusion or ascites which cause respiratory compromise; pre-existing neuropathy or predisposing colonic or sm bowel disorders.

CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0