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NCT01643499 · ClinicalTrials.gov registry record · Phase 1
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT01643499 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 79 participants.
The verdict
NCT01643499, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
This study is being done to determine the dose of a chemotherapy drug (irinotecan \[irinotecan hydrochloride\]) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin and is known as "FOLFIRINOX". FOLFIRINOX is a current drug therapy combination (or regimen) used for people with advanced pancreatic cancer, although this combination is not Food and Drug Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a separate clinical trial to increase survival compared to another commonly used drug in pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer, esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer, and cancers with an unknown primary location. The best dose of irinotecan to use in FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho \[UDP\] glucuronosyltransferase 1 family, polypeptide A1 \[UGT1A1\] gene) of subjects for the presence of an alteration in that gene, which may affect how the body handles irinotecan. Genes help determine some of the investigators individual characteristics, such as eye color, height and skin tone. Genes may also determine why people get certain diseases and how medicines may affect them. The result of the genetic analysis will divide subjects into one of three groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose of irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of irinotecan. Group C (approximately 10% of subjects) will receive an even lower dose of irinotecan
Interventions
- OTHER laboratory biomarker analysis
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2019-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01643499
The ClinicalTrials.gov registry entry for NCT01643499 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01643499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01643499 about?
NCT01643499 is a clinical study titled "Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies". This study is being done to determine the dose of a chemotherapy drug (irinotecan \[irinotecan hydrochloride\]) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists of 5-FU (fluorouracil), le...
What is the current status of trial NCT01643499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2012-03-26. Estimated completion is 2019-07.
What interventions are being tested in trial NCT01643499?
The interventions under investigation include: laboratory biomarker analysis (OTHER), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01643499?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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