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

NCT00748215 | Completed Phase 2 Results DMC

• 2 other identifiers: MDA-2008-0005CDR0000612205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Arm I: CASAD

EXPERIMENTAL

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.

Drug: calcium aluminosilicate anti-diarrheal

Arm II: Placebo

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

calcium aluminosilicate anti-diarrheal DRUG

Given orally

Arm I: CASAD

placebo OTHER

Given orally

Arm II: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Diarrhea; Colonic Neoplasms; Rectal Neoplasms

Interventions

Calcium Aluminosilicate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds

Results Point of Contact

• Title: Bryan Kee, MD/Assistant Professor, GI Medical Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

bkkee@mdanderson.org

713-792-2828

Study Officials

• Brian K. Kee, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Michael J. Fisch, MD, MPH, FACP

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: February 4, 2009
• Primary Completion: August 12, 2014
• Study Completion: August 12, 2014
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Locations

US (2)