Phase 2 Colorectal Cancer Trial, Recruiting NCT06728072 Sponsor: Virginia Commonwealth University Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06728072
Recruiting Phase 2

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 stage IV colorectal cancer
  • People whose cancer can be measured on scans using a standard set of medical measurement rules called RECIST 1.1
  • People who are planning to start a first-line chemotherapy regimen based on a drug called 5-fluorouracil (5FU) for colon cancer, with the specific regimen chosen by their treating doctor
  • People who previously received chemotherapy after surgery (adjuvant therapy), as long as it was completed more than 6 months ago
  • People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities)
  • People whose blood test results meet minimum levels for white blood cells, platelets, and haemoglobin (red blood cells), including if those levels were reached with a transfusion or other support
  • People whose liver enzyme levels (AST and ALT) fall within acceptable ranges — higher limits apply for those with known liver metastases (confirm with trial site)
  • People whose kidney function meets a minimum threshold, based on a blood test or a calculation using age, weight, and sex
  • People who are not pregnant and not currently breastfeeding
  • People of childbearing potential who agree to use an acceptable form of contraception throughout the study and for a period after treatment ends, as guided by their specific chemotherapy regimen
  • People already taking a daily aspirin regimen before the study — this does not need to be stopped to participate
  • People who have a medical reason they cannot take aspirin — participation is still possible, and aspirin would not be required as part of their study treatment

Who may not be able to join:

  • People who have had their entire colon surgically removed (total colectomy)
  • People who have been diagnosed with Cockayne Syndrome
  • People currently taking disulfiram, tizanidine, or theophylline who are unable to stop these medications for the duration of a specific part of the study treatment
  • People taking methotrexate at a dose of 15 mg per week or higher
  • People who have had an allergic reaction to ciprofloxacin, metronidazole, or aspirin
  • People who completed a full course of antibiotics (5 or more doses taken to treat a specific infection) in the 30 days before starting chemotherapy — note that antibiotics used for surgical prevention are allowed
  • People whose heart electrical activity, measured on a baseline ECG, shows a corrected QT interval above 480 (a specific heart rhythm measurement — confirm with trial site)
  • People who have been diagnosed with a condition that affects the body's ability to absorb nutrients from food (malabsorptive syndrome)
  • People who are unable to swallow tablets

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Emily Kinsey, MD, Virginia Commonwealth University

Phone: 804-628-6430

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

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
7 March 2025
Est. completion
1 July 2035

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Best response by analysis using Response Evaluation Criteria in Solid Tumors

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov