A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery.
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. Response Rate
4. Time to Progression-free survival
EXPLORATORY ENDPOINTS:
1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome
2. Short chain fatty acids analysis (promotion of acetic and butyric acid production)
3. Markers for gut inflammation such as fecal lipocalin 2
4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.
IRINOTECAN
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, New Brunswick
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers Cancer Institute of New Jersey-University Hospital
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.