Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients with Metastatic Colorectal Cancer
The goal of this clinical research study is to learn if calcium aluminosilicate anti-diarrheal (CASAD) can help to control diarrhea in patients with metastatic colorectal cancer who are receiving irinotecan. The safety of this drug will also be studied.
Disease Group: Colorectal,Gastrointestinal
Treatment Agent: CASAD
Treatment Location: Both at MDACC & Community Programs (CCOP/Network)
Estimatated Length of Stay in Houston: N/A
Sponsor: NCI,Salient Pharmaceuticals Incorporated
Return Visit: Patients will be seen during their pre-treatment visits for irrinotecan therapy
Home Care: N/A
1.1 Primary Objective To compare the efficacy of CASAD with that of placebo in reducing the incidence of Grade 3 or Grade 4 diarrhea after 6 weeks by CTCAE criteria in metastatic colorectal cancer patients receiving an Irinotecan-based chemotherapy regimen despite treatment with standard anti-diarrheal regimens. 1.2 Secondary Objectives 1.2.1 Compare the area under the curve of stools per day for CASAD vs. placebo. 1.2.2 Compare chemotherapy dose reductions and delays required due to diarrhea. 1.2.3 Explore functional impact of the study drug and the relative Impact of diarrhea in relation to other symptom issues - MDASI (M.D. Anderson Symptom Inventory) 1.2.4 Compare safety
IRB Review and Approval Date: 02/04/2009
Recruitment Status: Not Accepting
Projected Accrual: up to 100
1) Patients with metastatic colorectal cancer who are scheduled to
receive irinotecan alone or in combination with 5-FU, cetuximab,
leukovorin or other biologics, including Avastin.
2) Patients with one prior dose of irinotecan during current treatment regimen or patients with 2 or more prior doses of irinotican during current treatment regimen with a 4 week washout period.
3) Patients may have received any number or type of prior treatment regimens for metastatic disease or they may have received no prior treatment for metastatic disease.
4) Men and women from all ethnic and racial groups.
5) >/= 18 years old.
6) ECOG(Eastern Cooperative Oncology Group) Performance Status </= 2.
7) Adequate organ function: Total bilirubin < 1.5 x the institutional upper-normal limits (IUNL) AST (SGOT) and/or ALT (SGPT) < 2.5 x IUNL Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) < 5 x IUNL Alkaline phosphatase < 2.5 x IUNL Creatinine Clearance > 35 ml/min by Cockcroft-Gault
8) Adequate bone marrow function: Absolute neutrophil count > 1,000/microLiters; Platelets > 100,000/microLiters
9) Women of childbearing age and all men must agree to use adequate contraception(hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
10) Negative serum or urine pregnancy test for women of childbearing age.
11) Must have the ability to understand and the willingness to provide a written informed consent to participate in the study.
12) Brain metastasis must have been previously treated.
13) Asymptomatic for myocardial infarction.
1) History of allergies to irinotecan.
2) Known UGT1A1 deficiency with homozygotes.
3) Known history of Gilbert’s disease.
4) Patients with greater than grade one diarrhea.
5) Pregnancy or lactation.
6) History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
7) Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, symptomatic heart disease according to the NYHA class II or greater.
8) Serious uncontrolled active infection.
9) Patients who cannot comply with taking and documenting oral study medications.
10) Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications. PRN medications should also observe this window and follow as closely as possible, but may become a necessity to deviate from the 2 hour window.
11) Patients with uncontrolled brain metastasis.
12) Any chemotherapy, excluding irinotecan alone or in combination with other chemotherapy or biologic agents, within 2 weeks from Day 1 of study treatment initiation.
13) Concurrent radiation therapy.
14) Prior radiation therapy within 4 weeks of treatment initiation.