Phase 2
N=100
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Chemotherapeutic Agent Toxicity · Colorectal Cancer · Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00748215 ↗Enrolled (actual)
100
Serious AEs
13.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Grade 3/4 Diarrhea — 27; 26; 7; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- calcium aluminosilicate anti-diarrheal (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3/4 Diarrhea |
27; 26; 7; 3 | — |
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.
Eligibility 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:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) > 1,000/mm³
- Platelet count > 100,000/mm³
- Total bilirubin 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
Data sourced from ClinicalTrials.gov (NCT00748215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.