Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer
NCT00654160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-05-25
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.
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
Interventions
- DRUG
- DRUG
-
irinotecan hydrochloride
- DRUG
-
leucovorin calcium
- OTHER
-
pharmacogenomic studies
- OTHER
-
pharmacological study
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Robert McWilliams, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2010-11-30
- Completion
- 2012-12-03
Countries
- United States
Study Locations
More Related Trials
-
Combination Chemotherapy in Treating Patients With Advanced Cancer
NCT00021073 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
NCT00008060 ·Status: COMPLETED ·Phase: PHASE3
-
Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer
NCT00537121 ·Status: COMPLETED ·Phase: PHASE1
-
Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer
NCT01383343 ·Status: COMPLETED ·Phase: PHASE1
-
A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients
NCT01183494 ·Status: COMPLETED ·Phase: PHASE1
-
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
NCT04205968 ·Status: RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Colorectal Cancer
NCT00006103 ·Status: COMPLETED ·Phase: PHASE3
-
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
NCT00004885 ·Status: COMPLETED ·Phase: PHASE3
-
Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
NCT00091312 ·Status: UNKNOWN ·Phase: PHASE3
-
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
NCT00416767 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
NCT00003594 ·Status: COMPLETED ·Phase: PHASE3
-
Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
NCT02138617 ·Status: COMPLETED ·Phase: PHASE2
-
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
NCT00026273 ·Status: COMPLETED ·Phase: PHASE3
-
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
NCT00075595 ·Status: UNKNOWN ·Phase: PHASE2
-
FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
NCT02935764 ·Status: UNKNOWN ·Phase: PHASE3
-
Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
NCT00021281 ·Status: UNKNOWN ·Phase: PHASE3
-
Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
NCT00020488 ·Status: COMPLETED ·Phase: PHASE1
-
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
NCT03337087 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Irinotecan Hydrochloride With FOLFIRI and Cetuximab as First-Line Therapy in Treating Patients With RAS Wild-Type Colorectal Cancer
NCT02573220 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
NCT00183911 ·Status: COMPLETED ·Phase: PHASE2
-
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
NCT00514020 ·Status: COMPLETED ·Phase: PHASE2
-
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
NCT02366819 ·Status: SUSPENDED ·Phase: PHASE4
-
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
NCT00006115 ·Status: UNKNOWN ·Phase: PHASE2
-
Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
NCT00016952 ·Status: COMPLETED ·Phase: PHASE2
-
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
NCT00354978 ·Status: COMPLETED ·Phase: PHASE2