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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|