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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 Soft Tissue Sarcomas


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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 Soft Tissue Sarcomas


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 method of
contraception before entry into the study and throughout the same and for 6 months
after ending the study. Women of childbearing potential must have a negative urine
pregnancy test before study entry.

- Normal cardiac function with a Left ventricular ejection fraction (LVEF) ≥ 50% by
echocardiogram or Multiple Uptake Gated Acquisition Scan (MUGA).

Exclusion Criteria:

- Previous chemotherapy treatment.

- Previous radiotherapy involving the only localization(s) of measurable tumoral
disease.

- Performance status> 2 Eastern Cooperative Oncology Group(ECOG).

- Central Nervous System (CNS) metastases.

- Plasma bilirubin > upper limit of normal(ULN).

- Creatinine > 1.6 mg/dL.

- History of other neoplastic disease with the exception of basalioma or in situ
cervical cancer adequately treated.

- Significant cardiovascular disease (for example, dyspnea > 2 NYHA)

- Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 scale,
that limit patient availability, or according to investigator judgment may contribute
significantly to treatment toxicity.

- Uncontrolled bacterial, mycotic or viral infections.

- Women who are pregnant or breast-feeding

- Psychological, familial, social or geographic circumstances that limit the patient's
ability to comply with the protocol or informed consent.

- Patients participating in another clinical trial or receiving any other
investigational product.

- Patients who had participated in another clinical trial and/or had received any other
investigational product in the last 30 days prior to inclusion.

- The following histologic subtypes are excluded:

- Rhabdomyosarcoma

- Ewing's family of tumors

- Desmoplastic small round cell tumor

- Clear cell sarcoma

- Alveolar sarcoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Description:

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.

Outcome Time Frame:

2012

Safety Issue:

No

Principal Investigator

Javier Martin Broto, PhM

Investigator Role:

Principal Investigator

Investigator Affiliation:

GEIS

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

GEIS-20

NCT ID:

NCT01104298

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Sarcoma
  • Patients with advanced non operable and/or metastatic STS will be included.
  • Sarcoma

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