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Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan - NCT00748215-97225(Clinical Trial 240694)



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City:  Portland
State:  
OR
Zip Code: 97225
Conditions: Chemotherapeutic Agent Toxicity - Colorectal Cancer - Diarrhea
Purpose: 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.
Study summary: 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.
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: - ECOG performance status 0-2 - ANC > 1,000/mm³ - Platelet count > 100,000/mm³ - Total bilirubin < 1.5 times upper limit of normal (ULN) - AST and/or ALT < 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 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 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
Study is available at: CCOP - Columbia River Oncology Program
Portland, OR 97225
United States

Primary Contact:
Keith S. Lanier, MD
Phone: 503-216-6260
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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