Phase 2 Colorectal Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with colon cancer that has spread to other parts of the body, confirmed by a biopsy
- People whose doctors are planning to treat them with a second or later round of chemotherapy that includes a drug called irinotecan, starting at a specific dose
- People who have previously received irinotecan may still be considered, as long as they have been off that treatment for at least three months and their bowel movements have returned to their normal pattern
- People who are reasonably active and able to carry out daily activities (rated 0 or 1 on a standard activity scale used by doctors)
- People whose blood test results fall within acceptable ranges for things like immune cell counts, kidney function, liver function, and protein levels
- People who have not previously had genetic testing that identifies their UGT1A1 gene type (confirm with trial site)
Who may not be able to join:
- People who are currently experiencing moderate to severe diarrhea (having 4 or more extra bowel movements per day above their usual pattern)
- People who are unable to swallow or take oral supplements by mouth
- People who are currently taking antibiotics
- People who have a history of serious gut infections caused by certain bacteria, parasites, or viruses (such as Salmonella, C. difficile, Giardia, or Cytomegalovirus) that were linked to active infection and diarrhea, unless the infection was fully treated and bowel movements have been normal for at least three months
- People who have a history of ongoing gut conditions such as ulcerative colitis, Crohn's disease, coeliac disease, chronic pancreatitis, or any other long-term digestive condition associated with diarrhea
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Howard S Hochster, MD, Rutgers University
Phone: 732-235-2465
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting; Tumor Response by RECIST v1.1 Criteria
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.