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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colon Cancer||Drug: Curcumin Drug: 5-flurorouracil||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Feasibility Study of Curcumin in Combination With 5FU for Patients With 5FU-Resistant Metastatic Colon Cancer|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||September 13, 2019|
|Estimated Study Completion Date :||September 13, 2019|
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.
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
Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724202
|United States, Texas|
|Baylor Charles A. Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||John Preskitt, MD||Baylor University Medical Center/Texas Oncology, PA|