Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS (NCT01104298) | Clinical Trial Compass
TerminatedPhase 2
Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS
Stopped: Interim analysis did not show good results for main objective
Spain115 participantsStarted 2009-11
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* The patient must sign voluntarily the informed consent from before any study test is conducted that is not part of routine patient care, with the knowledge that he/she can abandon the study at any time without this affecting his/her previous care.
* Aged between 18 and 70.
* Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.
* The following histological subtypes can be included:
* Undifferentiated pleomorphic sarcoma (previously,malignant fibrous istiocytoma)
* Leiomyosarcoma
* Angiosarcoma
* Liposarcoma
* Synovial sarcoma
* Fibrosarcoma
* Hemangiopericytoma
* Neurofibrosarcoma
* Mixofibrosarcoma
* Unclassified sarcoma
* Measurable disease, according to RECIST criteria
* Performance status 0-2 Eastern Cooperative Oncology Group(ECOG).
* Adequate bone marrow function (hemoglobin \> 10 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥1.500/mm3, platelets ≥ 100.000/mm3). Patients with plasma creatinine ≤ 1,6 mg/dL, transaminases ≤2.5 times the upper limit of normal (ULN), total bilirubin ≤ upper limit of normal (ULN), CPK ≤ 2.5 times upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN) are acceptable. If the increase of alkaline phosphatase is \> 2.5 times the upper limit of normal (ULN), then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ upper limit of normal (ULN).
* Men or women of child bearing potential should be using an effective …
What they're measuring
1
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)