Status:
COMPLETED
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapeutic Agent Toxicity
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 p...
Detailed Description
OBJECTIVES: Primary * 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 colorect...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00748215
Start Date
February 4 2009
End Date
August 12 2014
Last Update
December 2 2020
Active Locations (2)
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1
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009