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Anti-metabolites

Open Label for Colon Cancer

Phase < 1
Waitlist Available
Led By John Preskitt, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

The purpose of this study is to test the safety and find the response rate of combining the dietary supplement, curcumin, with the standard of care, FDA-approved chemotherapy drug 5-fluorouracil (5FU, Adracil) and see what effects (good and bad) that the combined treatments have on colon cancer.

Eligible Conditions
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the safety using curcumin in patients with metastatic colon cancer; where toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary outcome measures
Duration of Quality of Life
Duration of overall survival
Duration of progression free survival
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment2 Interventions
All subjects will receive induction oral curcumin 500 mg twice per day for 2 weeks. Patients will continue on curcumin at same dose for an additional 6 weeks while being treated with 3 cycles of 5FU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
FDA approved

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,408 Total Patients Enrolled
John Preskitt, MDPrincipal InvestigatorBaylor University Medical Center/Texas Oncology, PA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025