Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
NCT ID: NCT00748215
Last Updated: 2020-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2009-02-04
2014-08-12
Brief Summary
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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.
Detailed Description
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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 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Arm I: CASAD
Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks.
calcium aluminosilicate anti-diarrheal
Given orally
Arm II: Placebo
Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
placebo
Given orally
Interventions
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calcium aluminosilicate anti-diarrheal
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian K. Kee, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Michael J. Fisch, MD, MPH, FACP
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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CCOP - Columbia River Oncology Program
Portland, Oregon, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MDA-2008-0005
Identifier Type: -
Identifier Source: secondary_id
CDR0000612205
Identifier Type: OTHER
Identifier Source: secondary_id
MDA-2008-0005
Identifier Type: -
Identifier Source: org_study_id