Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Condition: Chemotherapeutic Agent Toxicity; Colorectal Cancer; Diarrhea
MeSH terms: Colorectal Neoplasms; Diarrhea
Intervention: calcium aluminosilicate anti-diarrheal; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Antidiarrheals; Loperamide; Calcium Aluminosilicate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diarrhea; chemotherapeutic agent toxicity; recurrent colon cancer; recurrent rectal cancer; stage IV colon cancer; stage IV rectal cancer

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.
    

Eligibility 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