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
- Anal Cancer
- Carcinoma of the Appendix
- Colorectal Cancer
- Esophageal Cancer
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- Gastric Cancer
- Gastrointestinal Carcinoid Tumor
- Gastrointestinal Stromal Tumor
- Liver Cancer
- Pancreatic Cancer
- Small Intestine Cancer
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
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