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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
A maximum of 6 cycles every 3 weeks of doxorubicin monotherapy 75 mg/square meter will be given in the absence of progression or not acceptable toxicity.
A maximum of 6 cycles every 3 weeks of the combination (Trabectedin 1,1 mg/square meter + doxorubicin 60 mg/square meter) will be given in the absence of progression or not acceptable toxicity.
Ico Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
ICO Badalona
Badalona, Spain
H. Clinic Barcelona
Barcelona, Spain
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)
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). To this end, progression free survival will be compared between both groups of treatment.
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 activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.
Time frame: 2012
To determine the tumor control (response rates plus stabilizations) in both arms of treatment.
To determine the tumor control (response rates plus stabilizations) in both arms of treatment.
Time frame: 2012
Overall survival.
Overall survival.
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 activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).
Time frame: 2012
To determine toxicity of trabectedin/doxorubicin combination and the control arm.
To determine toxicity of trabectedin/doxorubicin combination and the control arm.
Time frame: 2012
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H. Sant Pau
Barcelona, Spain
H. Provincial Castellón
Castellon, Spain
ICO Girona
Girona, Spain
H. Xeral Cies
Lugo, Spain
Clinica Puerta Hierro
Madrid, Spain
H. Clínico. San Carlos
Madrid, Spain
H. U. La Paz
Madrid, Spain
...and 10 more locations
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 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 evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.
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