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

November 9, 2020 updated by: M.D. Anderson Cancer Center

Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: calcium aluminosilicate anti-diarrheal
Given orally
PLACEBO_COMPARATOR: 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.
Other: placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Grade 3/4 Diarrhea
Time Frame: 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.
First 6 weeks from baseline in initial intervention with CASAD or PLACEBO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Brian K. Kee, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2009

Primary Completion (ACTUAL)

August 12, 2014

Study Completion (ACTUAL)

August 12, 2014

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (ESTIMATE)

September 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDA-2008-0005
  • CDR0000612205 (OTHER: NCI Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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