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Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer

Colorectal Cancer Clinical Trial

Official title:
A Pharmacogenetic-Based Phase I Trial of Irinotecan, 5-Fluorouracil, and Leucovorin (FOLFIRI) in Patients With Advanced Gastrointestinal Cancer

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with fluorouracil and leucovorin in treating patients with advanced gastrointestinal cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- To determine the maximum tolerated dose of irinotecan hydrochloride in FOLFIRI for each respective UGT1A1 TA indel genotype grouping (group 1 [7/7, 7/8, 8/8], group 2 [6/7, 5/7, 5/8 ,6/8], and group 3 [6/6, 5/6, 5/5]).

Secondary

- Determine the molecular basis of toxicity, other than UGT1A1 variants, in FOLFIRI-treated cancer patients.

- Determine the pharmacodynamic molecular profiles of cell signaling pathways associated with the development and severity of early and late specific toxicities in cancer patients treated with FOLFIRI.

OUTLINE: This is a dose-escalation study of irinotecan hydrochloride. Patients are stratified according to genotype of UGT1A1 TA indel.

- Group 1 ( TA genotype 7/7, 7/8, 8/8): Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV bolus over 5 minutes followed by IV continuously over 46 hours on days 1-3.

- Group 2 (TA genotype 6/7, 6/7, 5/8, 6/8): Patients receive treatment as in group 1 with a higher initial dose of irinotecan hydrochloride.

- Group 3 (TA genotype 5/5, 5/6, 6/6): Patients receive treatment as in group 2. In all groups, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and periodically during study for pharmacokinetics, dihydropyridine deaminase enzyme assay, and pathway expression analysis.

After completion of study treatment, patients are followed every 6 weeks for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

  • Anal Cancer
  • Anus Neoplasms
  • Appendiceal Neoplasms
  • Bile Duct Neoplasms
  • Carcinoid Tumor
  • Carcinoma of the Appendix
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Gallbladder Neoplasms
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms
  • Liver Cancer
  • Liver Neoplasms
  • Malignant Carcinoid Syndrome
  • Neoplasms
  • Neuroendocrine Tumors
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Small Intestine Cancer
  • Stomach Neoplasms
Clinical Trial Details
NCT number NCT00654160
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date June 2008
Completion date December 3, 2012
View Details
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