Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.
|Anal Cancer Colorectal Cancer Esophageal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Liver Cancer Pancreatic Cancer Small Intestine Cancer||Drug: irinotecan hydrochloride Drug: oxaliplatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal Cancer|
|Study Start Date:||April 1998|
|Study Completion Date:||April 2002|
|Primary Completion Date:||April 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination chemotherapy regimen of oxaliplatin plus irinotecan when both drugs are given once a week for four weeks, followed by a two week rest, in patients with metastatic gastrointestinal cancer. II. Evaluate the toxicities of this combination chemotherapy when administered in this manner. III. Determine the pharmacokinetics of platinum and irinotecan at the MTD for this combination chemotherapy in this patient population.
OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 120 minutes, immediately followed by irinotecan IV over 30 minutes, weekly for 4 weeks (days 1, 8, 15, and 22). Courses are repeated every 42 days. Treatment continues in the absence of unacceptable side effects or disease progression. Sequential dose escalation of oxaliplatin is followed by sequential dose escalation of irinotecan. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects. Patients are followed approximately every 2-3 months.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18-36 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003427
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Nancy E. Kemeny, MD||Memorial Sloan Kettering Cancer Center|