Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer
Public ClinicalTrials.gov record NCT02333188. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Genotype-Guided Dosing Study of FOLFIRABRAX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
Study identification
- NCT ID
- NCT02333188
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 50 participants
Conditions and interventions
Conditions
- Adenocarcinoma of Unknown Primary
- Adult Cholangiocarcinoma
- Gallbladder Carcinoma
- Gastric Adenocarcinoma
- Malignant Gastrointestinal Neoplasm
- Metastatic Pancreatic Adenocarcinoma
- Pancreatic Adenocarcinoma
- Stage III Ampulla of Vater Cancer
- Stage III Pancreatic Cancer
- Stage IIIA Gallbladder Cancer
- Stage IIIA Gastric Cancer
- Stage IIIB Gallbladder Cancer
- Stage IIIB Gastric Cancer
- Stage IV Ampulla of Vater Cancer
- Stage IV Gallbladder Cancer
- Stage IV Gastric Cancer
- Stage IV Pancreatic Cancer
Interventions
- Paclitaxel Albumin-Stabilized Nanoparticle Formulation Drug
- Leucovorin Calcium Drug
- Irinotecan Hydrochloride Drug
- Fluorouracil Drug
- Laboratory Biomarker Analysis Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2014
- Primary completion
- Nov 30, 2017
- Completion
- Nov 30, 2017
- Last update posted
- May 30, 2023
2014 – 2017
United States locations
- U.S. sites
- 8
- U.S. states
- 4
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Fort Wayne Medical Oncology/Hematology | Fort Wayne | Indiana | 46845 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Virginia Mason | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02333188, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02333188 live on ClinicalTrials.gov.