Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of colorectal cancer
• * Metastatic disease
• Scheduled to receive irinotecan hydrochloride alone or in combination with fluorouracil, cetuximab, leucovorin calcium, or other biological therapy (including bevacizumab)
• No uncontrolled brain metastasis
• * Previously treated brain metastasis allowed
• PATIENT CHARACTERISTICS:
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) \> 1,000/mm³
• Platelet count \> 100,000/mm³
• Total bilirubin \< 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) \< 2.5 times ULN (\< 5 times ULN if liver metastasis is present)
• Alkaline phosphatase \< 2.5 times ULN
• Creatinine clearance \> 35 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known UDP-glucuronosyltransferase 1A1 (UGT1A1) deficiency with homozygotes.
• No known history of Gilbert's disease
• No diarrhea \> grade 1
• No serious illness or medical condition, including any of the following:
• * Uncontrolled congestive heart failure
• * Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg)
• * Uncontrolled arrhythmia
• * Active angina pectoris
• * Symptomatic heart disease according to New York Heart Association(NYHA) class II-IV
• No serious uncontrolled active infection
• No existing colostomy or ileostomy
• Not able to take and document oral study medications
• No history of allergies to irinotecan hydrochloride
• No history of significant neurological or psychiatric disorders that would preclude giving consent or participating in study treatment or follow up
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior treatment for metastatic disease allowed
• At least 4 weeks since prior irinotecan
• More than 2 weeks since prior chemotherapy
• * Irinotecan alone or in combination with other chemotherapy or biologic agents allowed
• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy
• No concurrent medication schedule that does not permit a 2-hour window between administration of calcium aluminosilicate anti-diarrheal (CASAD) and other medications