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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00748215 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Colorectal Cancer |
Drug: calcium aluminosilicate anti-diarrheal Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
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 may receive CASAD for an additional 6 weeks.
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Drug: calcium aluminosilicate anti-diarrheal
Given orally
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Arm II: Placebo Comparator
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 may then receive CASAD for 6 weeks.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of colorectal cancer
No uncontrolled brain metastasis
PATIENT CHARACTERISTICS:
No serious illness or medical condition, including any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000612205, MDA-2008-0005 |
Study First Received: | September 5, 2008 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00748215 |
Health Authority: | Unspecified |
diarrhea chemotherapeutic agent toxicity recurrent colon cancer |
recurrent rectal cancer stage IV colon cancer stage IV rectal cancer |
Diarrhea Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Loperamide Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Rectal neoplasm Calcium, Dietary Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Therapeutic Uses |
Gastrointestinal Agents Pharmacologic Actions Antidiarrheals |