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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00748215

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 II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Calcium Cancer Colorectal Cancer Diarrhea

Drug Information available for: Loperamide hydrochloride Loperamide Calcium gluconate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of grade 3 or 4 diarrhea as assessed by NCI CTCAE v3.0 [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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 may receive CASAD for an additional 6 weeks.	Drug: calcium aluminosilicate anti-diarrheal Given orally
Arm II: Placebo Comparator 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 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) vs 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, or other biological therapy (including bevacizumab)
No uncontrolled brain metastasis
- Previously treated brain metastasis allowed

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Leukocyte count > 3,000/mm³
ANC > 1,500/mm³
Platelet count > 100,000/mm³
Total bilirubin < 1.5 times upper limit of normal (ULN)
AST and/or ALT < 2.5 times ULN (< 5 times ULN if liver metastasis is present)
Alkaline phosphatase < 2.5 times ULN
Creatinine clearance > 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known UGT1A1 deficiency
No known history of Gilbert's disease
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
- History of myocardial infarction, stroke, or transient ischemic attack
No serious uncontrolled active infection
No existing colostomy or ileostomy
No inability to comply with taking and documenting 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
More than 4 weeks since prior chemotherapy
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

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

Locations

United States, Oregon
CCOP - Columbia River Oncology Program	Recruiting
Portland, Oregon, United States, 97225
Contact: Keith S. Lanier, MD 503-216-6260
United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Katrina Y. Glover, MD	M.D. Anderson Cancer Center
Investigator:	Michael J. Fisch, MD, MPH, FACP	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas M.D. Anderson CCOP Research Base ( Michael J. Fisch )
Study ID Numbers:	CDR0000612205, MDA-2008-0005
Study First Received:	September 5, 2008
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00748215 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

diarrhea
chemotherapeutic agent toxicity
recurrent colon cancer

recurrent rectal cancer
stage IV colon cancer
stage IV rectal cancer

Additional relevant MeSH terms:

Diarrhea
Digestive System Neoplasms
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Agents
Loperamide
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Antidiarrheals
Signs and Symptoms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009