Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
- To compare the efficacy of calcium aluminosilicate anti-diarrheal (CASAD) versus
placebo in reducing the incidence of grade 3 or 4 diarrhea in patients with metastatic
colorectal cancer receiving an irinotecan-based chemotherapy regimen.
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Incidence of grade 3 or 4 diarrhea as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Number of grade 3/4 diarrhea occurences used to compare the efficacy of Calcium Aluminosilicate Anti-Diarrheal (CASAD) with that of placebo in reducing the incidence of Grade 3 or Grade 4 diarrhea after 6 weeks by CTCAE criteria.
Brian K. Kee, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|