Status:
RECRUITING
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Lead Sponsor:
Howard S. Hochster, MD
Conditions:
Metastatic Colon Carcinoma
Stage IV Colon Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of...
Detailed Description
PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Resp...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Biopsy proven and metastatic colon cancer
- Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w.
- Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency.
- Performance Status (PS) 0-1
- Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) \>1500/uL; Creatinine \< 1.5 x Upper Limit of Normal (ULN); Transaminases \< 5x ULN; Bilirubin \< 1.5 x ULN; Albumin \> 3.0 g/dL
- No known UGTA1A\* genotype
- Exclusion Criteria
- Grade two diarrhea or greater (4-6 movements per day over baseline)
- Inability to take oral supplements
- Current antibiotic therapy
- Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection.
- History of the following infections and/or disease which could lead to diarrhea:
- History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool.
- History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.
Exclusion
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05296681
Start Date
May 3 2022
End Date
June 1 2027
Last Update
January 6 2026
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
2
Monmouth Medical Center
Lakewood, New Jersey, United States, 08701
3
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
4
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States, 07039