NCT00289809

TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients

A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

Detailed description

The Maximum Tolerated Dose of the combination was determined and the Phase I terminated. Then, Phase II study started.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	combination of TLC D-99 and Ifosfamide	* TLC D-99: 40 mg/m2 Day 1 every 3 weeks; * Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-02-10
• Last updated: 2009-12-18

Locations

1 site across 1 country: Italy