A genotype-guided dosing study of FOLFIRABRAX in previously untreated patients with advanced gastrointestinal malignancies
Brief description of study.
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.
Detailed description of study
The purpose of the proposed study is to determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of three uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) genotype groups (1/1, 1/28, 28/28) using genotype-guided dosing of irinotecan (irinotecan hydrochloride) as part of the FOLFIRABRAX regimen.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions:
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Age: 18 years - 100 years
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Gender: All
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