Phase
Condition
Colon Cancer
Colorectal Cancer
Treatment
NBT-NM108
Clinical Study ID
Ages > 18 All Genders
Study Summary
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.
Study Design
Study Description
Connect with a study center
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey 07202
United StatesSite Not Available
Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey 08690
United StatesActive - Recruiting
Monmouth Medical Center
Lakewood, New Jersey 08701
United StatesActive - Recruiting
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey 08701
United StatesActive - Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United StatesActive - Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesActive - Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesActive - Recruiting
The Cancer Center
Newark, New Jersey 07103
United StatesActive - Recruiting
Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey 08876
United StatesActive - Recruiting
Community Medical Center
Toms River, New Jersey 08753
United StatesActive - Recruiting
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