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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289809

Enrollment

Registered

2006-02-10

Start date

2006-09-30

Completion date

2009-12-31

Last updated

2009-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Soft Tissue

Brief 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.

Interventions

DRUGcombination 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide	Definition of TDL
Phase II: Response rate (CR/PR or SD)	Tumor assessment

Secondary

Measure	Time frame
Phase II: time to progression, duration of response, overall survival	Tumor assessment, follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026