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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT00654160
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • pharmacogenomic studies — OTHER
  • pharmacological study — OTHER

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Sep 2016
Primary completion
Nov 30, 2010
Completion
Dec 3, 2012

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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