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

NCT01104298 | Terminated Phase 2 DMC

• 2 other identifiers: GEIS-202008-008922-55
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 20

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

Conditions

Sarcoma

Keywords

metastatic STS; Trabectedin; doxorrubicin; soft tissue sarcoma; non operable sarcoma

Outcome Measures

Primary Outcomes (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)

  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.

  2012

Secondary Outcomes (7)

• To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.

  2012

• To determine the tumor control (response rates plus stabilizations) in both arms of treatment.

  2012

• Overall survival.

  2012

• To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).

  2012

• To determine toxicity of trabectedin/doxorubicin combination and the control arm.

  2012

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Classic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml. Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous

Drug: Doxorubicin

Arm B

EXPERIMENTAL

Trabectedin Presentation: vials with trabectedin 1 mg and sucrose 400 mg. Pharmaceutical form: A white or whitish lyophilized powder as concentrate for solution for injection. Route of administration: for intravenous use after reconstitution and further dilution. Classic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml. Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous

Drug: Trabectedin

Interventions

Doxorubicin DRUG

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.

Also known as: Adriamycin

Arm A

Trabectedin DRUG

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.

Also known as: Yondelis

Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• The following histologic subtypes are excluded:
• Rhabdomyosarcoma

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas: lead

Study Sites (20)

Ico Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Location

ICO Badalona

Badalona, Spain

Location

H. Clinic Barcelona

Barcelona, Spain

Location

H. Sant Pau

Barcelona, Spain

Location

H. Provincial Castellón

Castellon, Spain

Location

ICO Girona

Girona, Spain

Location

H. Xeral Cies

Lugo, Spain

Location

Clinica Puerta Hierro

Madrid, Spain

Location

H. Clínico. San Carlos

Madrid, Spain

Location

H. U. La Paz

Madrid, Spain

Location

H.U. Gregorio Marañon

Madrid, Spain

Location

H.U. Ramon Y Cajal

Madrid, Spain

Location

H.U. Clinico de Malaga

Málaga, Spain

Location

H. de Navarra

Navarra, Spain

Location

H. C. Asturias

Oviedo, Spain

Location

H. Son Dureta

Palma de Mallorca, Spain

Location

H. Univ. Canarias

Santa Cruz de Tenerife, Spain

Location

H.U. Virgen Del Rocio

Seville, Spain

Location

Instituto Valenciano de Oncología

Valencia, Spain

Location

H. Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Sarcoma; Ichthyosis, X-Linked

Interventions

Doxorubicin; Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Javier Martin Broto, PhM

  GEIS

  PRINCIPAL INVESTIGATOR

• Andres Poveda, Ph.M.

  GEIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2014
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

ES (20)