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

Primary Purpose

Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

calcium aluminosilicate anti-diarrheal

placebo

About this trial

This is an interventional supportive care trial for Chemotherapeutic Agent Toxicity focused on measuring diarrhea, chemotherapeutic agent toxicity, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CCOP - Columbia River Oncology Program
M. D. Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I: CASAD

Arm II: Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Grade 3/4 Diarrhea

One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.

Secondary Outcome Measures

Full Information

NCT ID

NCT00748215

First Posted

September 5, 2008

Last Updated

November 9, 2020

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00748215

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 4, 2009 (Actual)

Primary Completion Date

August 12, 2014 (Actual)

Study Completion Date

August 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea

Keywords

diarrhea, chemotherapeutic agent toxicity, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I: CASAD

Arm Type

Experimental

Arm Description

Arm Title

Arm II: Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

calcium aluminosilicate anti-diarrheal

Intervention Description

Given orally

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given orally

Primary Outcome Measure Information:

Title

Number of Participants With Grade 3/4 Diarrhea

Description

Time Frame

First 6 weeks from baseline in initial intervention with CASAD or PLACEBO

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian K. Kee, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael J. Fisch, MD, MPH, FACP

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

CCOP - Columbia River Oncology Program

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

M. D. Anderson Cancer Center at University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

Related Info

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

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