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NCT02138617 · ClinicalTrials.gov registry record · Phase 2
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT02138617: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT02138617 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138617, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study involves standard combination chemotherapy treatment for colon cancer, 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes". Genes are made of DNA and determine not only inherited traits or appearance (hair and eye color, height, body type, etc.) but also play an important role in health and how the body responds to illness and treatments for those illnesses. In this study, the investigators will examine the relationship between a patient's genes (DNA), or "genotype", and how the patient's body breaks down and removes or "metabolizes" the anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important role in how well this drug works against a patient's cancer as well as the adverse side effects the patient may experience. The current standard dose of irinotecan was determined in clinical trials without knowing individual genotypes and thus does not take into account a patient's ability to metabolize irinotecan. This means that based on one genotype the current standard dose of irinotecan may be correct or based on other genotypes the standard dose could result in lower and possibly less effective blood levels and result in significant under-dosing of irinotecan. Based on genotype the patient will be assigned to one of the following doses of irinotecan: * 180 mg/m2 (standard dose) * 260 mg/m2 * 310 mg/m2 The purpose of this research study is to determine if dosing irinotecan based on genotype is effective and safe for patients with colon cancer. Patient genotype will be determined from a small sample of blood and a laboratory test or "assay" performed at University of North Carolina Laboratories. For the purpose of this study, this assay is new and considered to be "investigational". This means that the genotype assay used in this study has not yet been approved by t
Primary Outcome
Progression-free Free Survival is defined as the time from day 1 (D1) of treatment to progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST)1.1 or death from any cause. Radiographic response will be measured by RECIST, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Irinotecan
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-05-06 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 2 |
What the finished NCT02138617 record still lists
NCT02138617 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT02138617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02138617 about?
NCT02138617 is a clinical study titled "Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer". This study involves standard combination chemotherapy treatment for colon cancer, 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes"...
What is the current status of trial NCT02138617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2014-05-06. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT02138617?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT02138617?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02138617's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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