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

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