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Metastatic Colon CancerEarly Phase 1NCT02724202

Curcumin in Combination With 5FU for Colon Cancer

A Early Phase 1 study testing Curcumin and 5-flurorouracil in people with Metastatic Colon Cancer, run by Baylor Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colon Cancer
What is being tested?
Curcumin and 5-flurorouracil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
20 Feb 2018to 10 Jan 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18 years or older, at the time of signing the informed consent.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer that is not response to standard 5FU based therapies.
  • Performance Status (PS) score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale.
  • Able to swallow and retain oral medication.
  • A female subject is eligible to participate if she is of:
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  • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 mili-internation unit (MIU)/ml and estradiol <40 pg/ml (140pmol/L) is confirmatory
  • Child-bearing potential and agrees to use a contraception method of abstinence, intrauterine device (IUD), barrier methods or birth control pills prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and until three months after the last dose of the study medication.
  • Male subjects must agree to use a method of contraception. This criterion must be followed from the time of the first dose of study medication until three months after the last dose of study medication.
  • Adequate organ system function defined as follows:
  • System Laboratory Values Hematologic Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L Hemoglobin ≥ 9.5 g/dL Platelets ≥ 75 x 10^9/L For subjects not on warfarin-based anticoagulants: Prothrombin time/International normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.1x upper limit of normal (ULN) INR (subjects on warfarin-based anticoagulant): 2-3 x ULN Hepatic Total bilirubin ≤ 1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) Aspartate aminotransferase (AST) and alanine transaminase (ALT) 1 ≤ 1.5x ULN Albumin ≥ 2.5 g/dL Renal Creatinine ≤ ULN; or Calculated creatinine clearance2 ≥ 50 mL/min; or Metabolic Fasting Serum Glucose < 250 mg/dL Cardiac Left Ventricular Ejection fraction (LVEF) ≥ lower limit of normal (LLN) by echocardiogram (ECHO) Blood pressure Systolic < 160 mm Hg and Diastolic < 100 mm Hg.
  • If liver metastases are present, AST and ALT ≤ 2.5x ULN is permitted
  • As calculated by Cockcroft-Gault formula.

Who cannot join

  • Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half-lives, whichever is shorter prior to the first dose of any one of the investigational drugs described in this study.
  • Unresolved toxicity by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE V4) of > Grade 1 from previous anti-cancer therapy.
  • Presence of active GI disease or other condition that could affect gastrointestinal absorption (malabsorption syndrome) or predispose a subject to GI ulceration.
  • Evidence of mucosal or internal bleeding
  • Any major surgery within the last four weeks
  • Uncontrolled diabetes mellitus
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  • Any malignancy related to human immunodeficiency virus (HIV), known history of HIV, history of known Hepatitis B virus (HBV) surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive Hepatitis C virus (HCV) antibody.
  • Known active infection requiring parenteral or oral anti-infective treatment.
  • Subjects with brain metastases are excluded if their brain metastases are:
  • Symptomatic
  • Treated (surgery, radiation therapy) but not clinically and radiographically stable one month after therapy (as assessed by at least 2 distinct contrast enhanced MRI or CT scans over at least a one month period), or
  • Asymptomatic and untreated but > 1 cm in the longest dimension
  • History or evidence of current clinically significant uncontrolled arrhythmias.
  • Subjects with controlled atrial fibrillation for >1 month prior to study Day 1 are eligible.
  • History of acute coronary syndromes (including unstable angina), myocardial infarction, coronary angioplasty, or stenting or bypass grafting within six months of screening.
  • Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject's safety or providing informed consent.
  • Known immediate or delayed hypersensitivity to any of the components of the study treatment(s).
  • Evidence of severe or uncontrolled systemic diseases (unstable or uncompensated respiratory, hepatic, renal, or cardiac disease, including unstable hypertension).
  • Pregnant or lactating females.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: A Pilot, Feasibility Study of Curcumin in Combination With 5FU for Patients With 5FU-Resistant Metastatic Colon Cancer

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.

Read the detailed description

Confirm clinical safety and identify clinical response rate of combination treatment with curcumin and 5FU in chemorefractory CRC patients. To determine whether curcumin administration induces systemic alterations in inflammatory and epigenetic biomarkers in patients with chemoresistant metastatic colorectal cancer (CRC). To correlate altered biomarker findings with clinical response according to RECIST V1.1 and survival criteria.

Being tested
Curcumin, 5-flurorouracil
Keywords
Curcumin, 5FU, 5-fluorouracil, Adracil, 5FU Resistant, Metastatic Colon Cancer, Colon Cancer
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDrug

    Also called BCM-95

    Curcumin is supplied as soft-gel capsule. It is a micronized rhizome extract containing phospholipids and 500mg of pure curcuminoids (95% curcumin, 5% desmethoxycurcumin) suspended in turmeric essential oil.

  • 5-flurorouracilDrug

    Also called 5FU, Adracil

    Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.

Study groups in NCT02724202
Study groupRoleWhat they receive
Open LabelExperimentalAll 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.
Receives: Drug: Curcumin; Drug: 5-flurorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Overall Response

    Recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the finding of target and non-target disease and will also take into consideration the appearance of new lesions.

    Measured: 12 months

  2. 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.

    Blood will be collected at baseline, after completing one cycle of curcumin treatment (2 weeks), and after completing three 2 week-cycles of 5FU (6 weeks) for inflammatory and epigenetic chemoresponsive biomarker profiling.

    Measured: Baseline, Week 2, Week 8

  3. Duration of response

    Measured: 12 months

  4. Duration of progression free survival

    Measured: 12 months

  5. Duration of overall survival

    Measured: 12 months

  6. Duration of Quality of Life

    All subjects will complete the quality of life survey at Baseline, 5FU treatment visits and follow-up visits.

    Measured: Baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study start20 Feb 2018
  3. Primary completion10 Jan 2020
  4. Study completion10 Jan 2020

Why it stopped: PI-Initiated study; PI requested closure

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02724202
Sponsor's protocol ID
014-143
Status last verified
Jan 2026
First submitted
16 Mar 2016
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Curcumin and 5-flurorouracil in people with Metastatic Colon Cancer, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: PI-Initiated study; PI requested closure). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02724202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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