Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 100 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02138617
The ClinicalTrials.gov registry entry for NCT02138617 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT02138617 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.