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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00748215
First received: September 5, 2008
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Chemotherapeutic Agent Toxicity
Colorectal Cancer
Diarrhea
Drug: calcium aluminosilicate anti-diarrheal
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of grade 3 or 4 diarrhea as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of grade 3/4 diarrhea occurences used to compare the efficacy of Calcium Aluminosilicate Anti-Diarrheal (CASAD) with that of placebo in reducing the incidence of Grade 3 or Grade 4 diarrhea after 6 weeks by CTCAE criteria.


Secondary Outcome Measures:
  • Number of Stools per day [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Chemotherapy dose reductions and delays due to diarrhea [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the MD Anderson Symptom Inventory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2009
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748215

Locations
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Brian K. Kee, MD M.D. Anderson Cancer Center
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00748215     History of Changes
Other Study ID Numbers: MDA-2008-0005, MDA-2008-0005, CDR0000612205
Study First Received: September 5, 2008
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
diarrhea
chemotherapeutic agent toxicity
recurrent colon cancer
recurrent rectal cancer
stage IV colon cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Diarrhea
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Antidiarrheals
Loperamide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014