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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea

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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 ProgramPortland, Oregon  97225
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009