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Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma

2014-08-27 03:56:53 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have unresectable advanced or metastatic soft tissue sarcoma.

Description

OBJECTIVES: I. Determine the rate of clinical benefit, in terms of the incidence of objective partial and complete response, stable disease, or minor response of more than 3 months duration, in patients with previously treated, unresectable advanced or metastatic soft tissue sarcoma treated with ecteinascidin 743. II. Determine the progression-free survival, overall survival, and response duration in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the pharmacokinetic-pharmacodynamic relationship of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to number of prior cytotoxic therapies for advanced disease (1-2 vs more than 2). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-76 patients (18-38 per stratum) will be accrued for this study within 13 months.

Study Design

Primary Purpose: Treatment

Conditions

Sarcoma

Intervention

trabectedin

Location

Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:53-0400

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A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

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PubMed Articles [9 Associated PubMed Articles listed on BioPortfolio]

Impact of Trabectedin Interruption and Subsequent Rechallenge on Progression in Patients With Advanced Soft Tissue Sarcoma: Long-term Follow-up of the T-DIS trial.

To assess the impact of trabectedin rechallenge.

Prospective assessment of the predictive value of the BRCA1 gene status in sarcoma patients treated with trabectedin: an updated analysis of the EORTC 62091 trial.

We describe the predictive value of BRCA1 gene status on trabectedin efficacy and found no correlation despite the mechanisms of action of this drug that rely on DNA repair systems.

Body Mass Index as a Risk Factor for Toxicities in Patients with Advanced Soft-Tissue Sarcoma Treated with Trabectedin.

Low body mass index (BMI) and/or low lean body mass have been shown to be risk factors for chemotherapy-related toxicities in a number of different cancers. However, no data are available regarding th...

HMGA1/E2F1 axis and NFkB pathways regulate LPS progression and trabectedin resistance.

Although the medical treatments of sarcoma have evolved in the last years, a significant portion of patients develops recurrence after therapies suggesting the need to identify novel targets to improv...

Readily prepared biodegradable nanoparticles to formulate poorly water soluble drugs improving their pharmacological properties: The example of trabectedin.

The improvement of the pharmacological profile of lipophilic drug formulations is one of the main successes achieved using nanoparticles (NPs) in medicine. However, the complex synthesis procedure and...

Medical and Biotech [MESH] Definitions

An experimental sarcoma of mice.

An experimental sarcoma of mice.

An experimental sarcoma of rats.

Experimentally induced neoplasms of CONNECTIVE TISSUE in animals to provide a model for studying human SARCOMA.

A family of transforming proteins isolated from retroviruses such as MOUSE SARCOMA VIRUSES. They are viral-derived members of the raf-kinase family of serine-theonine kinases.

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