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

OBJECTIVES:

Primary

- To compare the efficacy of calcium aluminosilicate anti-diarrheal (CASAD) vs placebo in
reducing the incidence of grade 3 or 4 diarrhea in patients with metastatic colorectal
cancer receiving an irinotecan-based chemotherapy regimen.

Secondary

- To compare stools per day in patients treated with these drugs.

- To compare chemotherapy dose reductions and delays due to diarrhea in patients treated
with these drugs.

- To compare quality of life of patients treated with these drugs.

- To compare the safety of these drugs in these patients.

- To compare the incidence of grade 3 or 4 diarrhea in patients treated with these drugs.

OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy
regimen (irinotecan hydrochloride in combination with fluorouracil and/or biologic therapy
vs irinotecan hydrochloride alone). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times
daily for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients who develop grade 3 or 4 diarrhea and are removed from the study may receive
CASAD for an additional 6 weeks.

- Arm II: Patients receive oral placebo 4 times daily for 6 weeks in the absence of
disease progression or unacceptable toxicity. Patients who develop grade 3 or 4
diarrhea and are removed from the study may then receive CASAD for 6 weeks.

Patients undergo quality-of-life assessment at baseline and at weeks 3, 5, and 6.

After completion of study treatment, patients are followed for 30 days.