A Study of the Safety and Effectiveness of Trabetedin Versus Doxorubicin-Based Chemotherapy in Patients With Translocation-Related Sarcomas (TRS)

This study is not yet open for participant recruitment.

Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., April 2009

First Received: November 20, 2008 Last Updated: April 30, 2009 History of Changes

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00796120

Purpose

A randomized, multicenter, Phase III trial to evaluate the effeciveness of trabectedin versus standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced TRS, by comparing progression-free survival (PFS) in the two treatment arms.

Condition	Intervention	Phase
Translocation-Related Sarcomas (TRS) Soft Tissue Sarcomas	Drug: Trabectedin, ET 743 and Yondelis	Phase III

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Ecteinascidin 743

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-Based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To evaluate the effectiveness of trabetedin compared to standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced TRS, by comparing progression-free survival (PFS).

Secondary Outcome Measures:

To compare; PFS at 6 months, response rates and duration of response, exploratory evaluations using Choi response criteria, PFS and RR in subgroups of patients stratified by histological type, overall survival and safety profile in each arm

Estimated Enrollment:

Detailed Description:

Treatment Arm A: Trabectedin. Treatment Arm B: Doxorubicin as a single agent or in combination with ifosfamide

Trabectedin 1.5 mg/m2 given intravenously over 24-hours; or doxorubicin 75 mg/m2 intravenously every 3 weeks, or doxorubicin 60 mg/m2 intravenously followed by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide chemoprotectant drugs.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients (age >=18 years)
Pathological diagnosis of TRS (institutional assessment)
Patients must have unresectable locally advanced or metastatic disease prior to enrollment
ECOG PS score of 0-2
Adequate cardiac function

Exclusion Criteria:

Known hypersensitifity to any components of the intravenous (i.v.) formulation of trabectedin or the comparator
Prior chemotherapy treatment of irradiation of the lesion
Brain metastases and/or leptomeningeal metastases, even if treated
Pregnant or lactating women
History of another neoplastic disease unless in remission for five years or more

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796120

Contacts

Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email

info1@veritasmedicine.com

Locations

Germany

Mannheim, Germany, D-68135

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PharmaMar

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Study ID Numbers:	CR015769
Study First Received:	November 20, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00796120 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Soft Tissue Sarcomas

Study placed in the following topic categories:

Ecteinascidin 743
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor

Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Doxorubicin

Additional relevant MeSH terms:

Ecteinascidin 743
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009