Trial | NCT00289809  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.

Then, Phase II study started.
Study Started
Sep 30
2006
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Dec 18
2009
Estimate

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

Criteria 

Inclusion Criteria:

Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
Age >/=18 yrs
PS </=2
Disease detectable almost for 1 dimension
Life expectancy >/=3 mos
Minimum 4 wks from last radiotherapy
Adequate medullary, liver, and renal functions
Normal LVEF
Written Informed Consent

Exclusion Criteria:

Pregnant or breast-feeding patients
Serious concomitant disease or not controlled infections
No Results Posted