Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically documented metastatic colorectal cancer
• •* The site of the primary lesion must be or have been confirmed endoscopically, surgically, or radiologically to have been in the colon or rectum
• •* Patients with a history of histologically proven colorectal cancer treated by surgical resection and who develop radiological or clinical evidence of metastatic cancer do not require additional histological or cytological confirmation of metastatic disease unless either of the following are true:
• •* An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease
• •* The primary cancer was stage I
• •Must have measurable disease, defined as in at least one dimension (longest dimension to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• •* Lesions that are considered nonmeasurable include the following:
• •* Bone lesions
• •* Leptomeningeal disease
• •* Ascites
• •* Pleural/pericardial effusion
• •* Lymphangitis cutis/pulmonis
• •* Abdominal masses that are not confirmed and followed by imaging techniques
• •* Cystic lesions
• •Must have received one and only one prior regimen for metastatic disease containing oxaliplatin, a fluoropyrimidine, and bevacizumab
• •* Patients who discontinue oxaliplatin due to toxicity are eligible provided they progressed on the fluoropyrimidine component with or without bevacizumab
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •ANC ≥ 1,500/μL
• •Platelet count ≥ 100,000/μL
• •Hemoglobin ≥ 8 g/dL
• •Leukocytes ≥ 3,000/mm³
• •Calculated creatinine clearance \> 50 mL/min
• •ALT/AST ≤ 2.5 times upper limit of normal (ULN)
• •Urine protein \< 1+ protein OR protein \< 1g by 24-hour urine collection and urine protein:creatinine ratio \< 1.0
• •Total bilirubin normal
• •Not pregnant or nursing
• •Negative pregnancy test
• •No known end-stage liver disease or active hepatitis
• •No colonic or small bowel disorders (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) that predispose to diarrhea in which the symptoms are uncontrolled as indicated by baseline pattern of \> 3 watery or soft stools daily in patients without a colostomy or ileostomy
• •* Patients with a colostomy or ileostomy may be entered at investigator discretion
• •History of hypertension allowed provided it is well controlled (BP \< 150/90 mm Hg) on a regimen of antihypertensive therapy
• •No concurrent congestive heart failure (New York Heart Association class III or IV)
• •No significant history of bleeding events or gastrointestinal (GI) perforation