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Curcumin in Combination With 5FU for Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724202
Recruitment Status : Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 31, 2016
Last Update Posted Date July 11, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
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 ]
Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02724202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Overall Response [ Time Frame: 12 months ]
    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.
  • 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. [ Time Frame: Baseline, Week 2, Week 8 ]
    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.
  • Duration of response [ Time Frame: 12 months ]
  • Duration of progression free survival [ Time Frame: 12 months ]
  • Duration of overall survival [ Time Frame: 12 months ]
  • Duration of Quality of Life [ Time Frame: Baseline, 12 months ]
    All subjects will complete the quality of life survey at Baseline, 5FU treatment visits and follow-up visits.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
  • Overall Response [ Time Frame: 12 months ]
    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.
  • 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. [ Time Frame: 8 weeks ]
    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.
  • Duration of response [ Time Frame: 12 months ]
  • Duration of progression free survival [ Time Frame: 12 months ]
  • Duration of overall survival [ Time Frame: 12 months ]
  • Duration of Quality of Life [ Time Frame: 12 months ]
    All subjects will complete the quality of life survey at Baseline, 5FU treatment visits and follow-up visits.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin in Combination With 5FU for Colon Cancer
Official Title  ICMJE A Pilot, Feasibility Study of Curcumin in Combination With 5FU for Patients With 5FU-Resistant Metastatic Colon Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colon Cancer
Intervention  ICMJE
  • Drug: Curcumin
    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.
    Other Name: BCM-95
  • Drug: 5-flurorouracil
    Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.
    Other Names:
    • 5FU
    • Adracil
Study Arms  ICMJE Experimental: Open Label
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.
Interventions:
  • Drug: Curcumin
  • Drug: 5-flurorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 20, 2019)
13
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2016)
14
Estimated Study Completion Date  ICMJE September 13, 2019
Estimated Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

  1. If liver metastases are present, AST and ALT ≤ 2.5x ULN is permitted
  2. As calculated by Cockcroft-Gault formula.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02724202
Other Study ID Numbers  ICMJE 014-143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Preskitt, MD Baylor University Medical Center/Texas Oncology, PA
PRS Account Baylor Research Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP