NCT00374660

Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 40 to 80 mg/m\^2 by dose escalations in 10 mg/m2 increments if no dose-limiting toxicity.
DRUG	Irofulven	Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered as a 30-minute infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 0.30 to 0.40 mg/kg if no dose-limiting toxicity.

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-09-11
• Last updated: 2021-12-08

Locations

7 sites across 1 country: France