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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

September 5, 2008
August 14, 2014
February 2009
August 2014   (final data collection date for primary outcome measure)
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.
Incidence of grade 3 or 4 diarrhea as assessed by NCI CTCAE v3.0 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00748215 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Stools per day [ Designated as safety issue: No ]
  • Chemotherapy dose reductions and delays due to diarrhea [ Designated as safety issue: Yes ]
  • Safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the MD Anderson Symptom Inventory [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Chemotherapeutic Agent Toxicity
  • Colorectal Cancer
  • Diarrhea
  • Drug: calcium aluminosilicate anti-diarrheal
    Given orally
  • Other: placebo
    Given orally
  • 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.
    Intervention: Drug: calcium aluminosilicate anti-diarrheal
  • 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.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00748215
MDA-2008-0005, MDA-2008-0005, CDR0000612205
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian K. Kee, MD M.D. Anderson Cancer Center
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP