Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea
Trial Information
Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
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.
Inclusion 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
Type of Study:
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
Outcome Measure:
Incidence of grade 3 or 4 diarrhea as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome Description:
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.
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Brian K. Kee, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
MDA-2008-0005
NCT ID:
NCT00748215
Start Date:
February 2009
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Colorectal Cancer
- Diarrhea
- diarrhea
- chemotherapeutic agent toxicity
- recurrent colon cancer
- recurrent rectal cancer
- stage IV colon cancer
- stage IV rectal cancer
- Colorectal Neoplasms
- Diarrhea
Name | Location |
|---|---|
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
