Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan

Phase 2

Completed

• Conditions: Chemotherapeutic Agent Toxicity; Diarrhea; Colorectal Cancer
• Interventions: Drug: calcium aluminosilicate anti-diarrheal; Other: placebo

• Registration Number: NCT00748215
• Lead Sponsor: M.D. Anderson Cancer Center

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 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.

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 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.

Study Timeline

• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Study Start: 2009-02-04
• Primary Completion: 2014-08-12
• Study Completion: 2014-08-12
• Results First Submitted: 2020-09-02
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-09
• Last Update Submitted: 2020-11-09
• Results First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I: CASAD	calcium aluminosilicate anti-diarrheal	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.
Arm II: Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Grade 3/4 Diarrhea	First 6 weeks from baseline in initial intervention with CASAD or PLACEBO	One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.

Trial Locations

Locations (2)

CCOP - Columbia River Oncology Program; 🇺🇸 Portland, Oregon, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States