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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Duration of Quality of Life
Evidence of altered biomarker status (circulating DNA methylation status, miRNA profile) at 8 weeks post-treatment according to RECIST version 1.1 and survival criteria.
Overall Response
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
205 Previous Clinical Trials
203,402 Total Patients Enrolled
John Preskitt, MDPrincipal InvestigatorBaylor University Medical Center/Texas Oncology, PA
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