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

• Status: Completed
• Trial end date: 2014-08-12
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in patients receiving irinotecan.

PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared with a placebo in treating and preventing diarrhea in patients with metastatic colorectal cancer receiving irinotecan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antidiarrheals; Calcium; Calcium Aluminosilicate; Calcium, Dietary; Loperamide

Criteria

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