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

Completed · Phase 1

Conditions studied: 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

In brief

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 facts

Study ID

NCT00654160

Run by

Mayo Clinic

People needed

7

Starts

2008-06-01

Expected to finish

2012-12-03

Last updated by the study team

2017-05-25

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Life expectancy ≥ 12 weeks.
• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• SGOT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases)
• Total Bilirubin ≤ ULN for patients in group 3 and ≤ 2.0 times ULN for patients in groups 1 and 2
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for the duration of study treatment
• Willing to provide blood samples for mandatory translational studies

You may not qualify if…

• Known allergy to irinotecan hydrochloride-related agents (e.g., topotecan), 5-fluorouracil, and/or leucovorin calcium
• Active or uncontrolled infection
• Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
• PRIOR CONCURRENT THERAPY:
• Recovered from all toxicities
• More than 4 weeks since prior major surgery
• More than 2 weeks since completion of prior radiotherapy
• No prior radiotherapy to > 25% of bone marrow
• More than 2 week since prior cytotoxic chemotherapy, biologic therapy, or immunotherapy
• No concurrent sargramostim (GM-CSF)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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