Clinical trial · Interventional
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
NCT00748215CI-TRIAL-00048602completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diarrhea | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium aluminosilicate anti-diarrheal | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: CASAD
- description
- 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.
- interventionNames
- Drug: calcium aluminosilicate anti-diarrheal
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.