Sunitinib Malate and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the rectum
• * Lower pole of the tumor \< 12 cm from the anal margin
• Synchronous metastases of the liver and/or lung
• * Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation
• Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)
• No rectal obstruction requiring surgery or the emergency fitting of a prosthesis
• No CNS metastases
• PATIENT CHARACTERISTICS:
• WHO performance status 0-2
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine clearance ≥ 60 mL/min
• Hemoglobin ≥ 10 g/dL (transfusions allowed)
• FEV ≥ 50%
• QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)
• Total bilirubin ≤ 1.5 times upper limit of normal
• Serum albumin ≥ 25 g/L
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
• * History of other cancers allowed provided the patient has been disease-free \> 3 years
• None of the following:
• * Congestive heart failure or coronary heart disease
• * Myocardial infarction within the past year
• * Uncontrolled hypertension (systolic BP \> 160 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
• No active severe rectal bleeding
• No liver failure
• No known Gilbert syndrome
• No severe uncontrolled infection
• No chronic diarrhea, malabsorption syndrome, or intestinal obstruction/subocclusion
• No severe uncontrolled pain (visual analogue scale 5/10) with morphine treatment
• No other medical, psychological, or social condition that, in the investigator's opinion, could affect the patient's compliance with study treatment
• No hypersensitivity to any component of study treatment
• PRIOR CONCURRENT THERAPY:
• See Patient Characteristics
• No prior radiotherapy to the pelvis
• More than 4 weeks since prior experimental therapy
• More than 7 days since prior CYP3A4 inhibitor before the administration of sunitinib malate
• More than 12 days since prior CYP3A4 inducer
• No concurrent participation in another clinical study
• No other concurrent anticancer therapy