Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metas… (NCT00748215) | Clinical Trial Compass
CompletedPhase 2
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
United States100 participantsStarted 2009-02-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Grade 3/4 Diarrhea
Timeframe: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO