Curcumin in Combination With 5FU for Colon Cancer

NCT02724202 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 014-143
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colon Cancer

Keywords

Curcumin; 5FU; 5-fluorouracil; Adracil; 5FU Resistant; Metastatic Colon Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (6)

• Overall Response

  12 months

• 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.

  Baseline, Week 2, Week 8

• Duration of response

  12 months

• Duration of progression free survival

  12 months

• Duration of overall survival

  12 months

Study Arms (1)

Open Label

EXPERIMENTAL

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.

Drug: Curcumin; Drug: 5-flurorouracil

Interventions

Curcumin DRUG

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.

Also known as: BCM-95

Open Label

5-flurorouracil DRUG

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

Also known as: 5FU, Adracil

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Curcumin; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John Preskitt, MD

  Baylor University Medical Center/Texas Oncology, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 31, 2016
• Study Start: February 20, 2018
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)