Clinical Trial: Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized, Open, Multicenter, Prospective, Phase II Clinical Trial of Doxorubicin vs. Trabectedin Plus Doxorubicin in the First Line Treatment of Patients With Advanced Non Operable and/or Metastatic

Brief Summary: The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy

Detailed Summary:

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy.

This proposal arises from the need to bring to the first line of treatment of advanced STS agents that have shown activity in second line. The goal is to improve available standard treatments. Tumors in patients not previously exposed to chemotherapy have not been selected in their biological behavior and they are the best scenario to test antitumor activity of a new anticancer drug.

The combination of drugs with different mechanisms of action may be a clear advantage to obtain better results and potential synergy. On the other hand, the toxicity profiles of both study drugs are different and worsening or summative of adverse effects is not expected.

The purpose of this study is to determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS).

Sponsor: Grupo Espanol de Investigacion en Sarcomas

Current Primary Outcome: To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS) [ Time Frame: 2012 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm. [ Time Frame: 2012 ]
  To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.
• To determine the tumor control (response rates plus stabilizations) in both arms of treatment. [ Time Frame: 2012 ]
  To determine the tumor control (response rates plus stabilizations) in both arms of treatment.
• Overall survival. [ Time Frame: 2012 ]
  Overall survival.
• To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study). [ Time Frame: 2012 ]
  To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).
• To determine toxicity of trabectedin/doxorubicin combination and the control arm. [ Time Frame: 2012 ]
  To determine toxicity of trabectedin/doxorubicin combination and the control arm.
• To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters. [ Time Frame: 2012 ]
  To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters.
• To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints. [ Time Frame: 2012 ]
  To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.

Original Secondary Outcome:

• To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm. [ Time Frame: 2012 ]
  To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.
• To determine the tumor control (response rates plus stabilizations) in both arms of treatment. [ Time Frame: 2012 ]
  To determine the tumor control (response rates plus stabilizations) in both arms of treatment.
• Overall survival. [ Time Frame: 2012 ]
  Overall survival.
• To determine activity by tissue changes applying the Choi criteria to STS (see radiological review sub study). [ Time Frame: 2012 ]
  To determine activity by tissue changes applying the Choi criteria to STS (see radiological review sub study).
• To determine toxicity of trabectedin/doxorubicin combination and the control arm. [ Time Frame: 2012 ]
  To determine toxicity of trabectedin/doxorubicin combination and the control arm.
• To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters. [ Time Frame: 2012 ]
  To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters.
• To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints. [ Time Frame: 2012 ]
  To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.

Information By: Grupo Espanol de Investigacion en Sarcomas

Dates:
Date Received: April 13, 2010
Date Started: November 2009
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015