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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. 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. SECONDARY OBJECTIVES: I. To determine the cumulative dose of each chemotherapy drug (nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation], irinotecan, 5-FU [fluorouracil]) administered in each genotype group. II. To determine the response rates (in patients with measurable disease) by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) for each different disease (pancreatic cancer, biliary tract cancer, esophageal/gastric cancer, adenocarcinoma of unknown primary) treated in the study. OUTLINE: Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma of Unknown Primary
  • Adult Cholangiocarcinoma
  • Cholangiocarcinoma
  • Digestive System Neoplasms
  • Gallbladder Carcinoma
  • Gallbladder Neoplasms
  • Gastric Adenocarcinoma
  • Gastrointestinal Neoplasms
  • Malignant Gastrointestinal Neoplasm
  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Neoplasms
  • 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
  • Stomach Neoplasms

NCT number NCT02333188
Study type Interventional
Source University of Chicago
Contact
Status Completed
Phase Phase 1
Start date December 2014
Completion date December 2017

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