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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 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue

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Trial Information

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


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

Then, Phase II study started.


Inclusion Criteria:



- Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months
from the last chemotherapy

- Age >/=18 yrs

- PS
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide

Outcome Time Frame:

Definition of TDL

Safety Issue:

Yes

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2005-001

NCT ID:

NCT00289809

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma

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