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NCT01859858 · ClinicalTrials.gov registry record · Phase 1
Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors
A Phase 1 study of Advanced Colorectal Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 2
- Study locations
NCT01859858: Completed Phase 1 study of Advanced Colorectal Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01859858 is a Phase 1 study of Advanced Colorectal Cancer that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 23 participants, below the 180-participant average among 8 other Advanced Colorectal Cancer trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859858, a Phase 1 study of Advanced Colorectal Cancer, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 2
- Study locations
Study Summary
Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin during their treatment for cancer because of the purported health benefits. This research study is designed to learn more about the safety, pharmacokinetics and effectiveness of irinotecan when given in combination with curcumin in patients with metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better understand the interaction between curcumin and irinotecan by measuring levels of irinotecan in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information collected from this study could result in improved dosing guidelines and lead to more effective treatment of your cancer with less toxicity.
Primary Outcome
During Part 1 of study dose escalation will be used to determine the MTD of curcumin based on a DLT rate of 0.25 for the combination with irinotecan.
Conditions Studied
Interventions
- DRUG Irinotecan
- DIETARY_SUPPLEMENT curcumin
Study Locations (2)
Indiana
- IU Simon Cancer Center - Indianapolis
North Carolina
- University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-10-05 |
| Phase | Phase 1 |
What the finished NCT01859858 record still lists
NCT01859858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 180-participant average among 8 other Advanced Colorectal Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Advanced Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Irinotecan is the first listed.
NCT01859858 reports a single indexed study location in Indiana, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01859858 about?
NCT01859858 is a clinical study titled "Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors". Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin during their treatment f...
What is the current status of trial NCT01859858?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2013-06. Estimated completion is 2016-10-05.
What conditions does trial NCT01859858 study?
This clinical trial studies the following conditions: Advanced Colorectal Cancer.
What interventions are being tested in trial NCT01859858?
The interventions under investigation include: Irinotecan (DRUG), curcumin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01859858?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859858 being conducted?
This trial has 2 study locations across Indiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01859858's enrollment target sits among peer trials
23 8th of 8 higher than 1 of 8 other Advanced Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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