A Study to Provide Access to Trabectedin in Patients With Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210665

Purpose

The purpose of this study is to provide access to treatment with trabectedin before the drug is commercially available and reimbursable to patients who previously received treatment for soft tissue sarcoma, who have relapsed or who are refractory to/intolerant of standard therapies for treatment of soft tissue sarcoma but who may benefit from treatment with trabectedin.

Condition	Intervention	Phase
Sarcoma	Drug: trabectedin	Phase III

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ecteinascidin 743

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Multicenter, Open-Label Single-Arm Study of Trabectedin for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

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

Primary Outcome Measures:

Incidence of adverse events and change in physical examinations, vital signs, ECOG performance status, clinical laboratory tests, and electrocardiogram results from the start of the study to the end of the study [ Time Frame: 8 weeks after Last Patient Out of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

May collect follow-up survival data [ Time Frame: 8 weeks after Last Patient Out of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2005
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
001: Experimental	Drug: trabectedin 1.5mg/m2 as 24hr infusion on day 1 of each 30 day cycle

Detailed Description:

Trabectedin is the first of a new class of antitumor agents. Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage, disease stabilization, and improved survival rates. However, hematologic toxicity, hepatic toxicity, and renal impairment were also observed in these patients. This is a single-arm, open-label, multicenter, study that is designed to provide access to trabectedin in patients with soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma. Safety evaluation will include physical examinations, monitoring of vital signs and adverse events, and assessing clinical laboratory test and 12-lead electrocardiogram results. Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) performance status will also be assessed.

1.5 mg/m2 trabectedin reconstituted and diluted to 500 mL volume, administered by central venous line over 24 hours at start of each 21-day treatment cycle; 20 mg dexamethasone, anti-inflammatory agent, administered by vein 30 minutes before each trabectedin dose. Number of cycles response dependent

Eligibility

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

Criteria

Inclusion Criteria:

Male or female patients >=18 years of age
Soft tissue sarcoma that cannot be surgically removed and is in an advanced stage or has spread
Must have relapsed or had progressive disease following standard of care treatment prior to enrollment or intolerant to standard of care treatment due to safety issues
Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (criteria used to grade the severity of toxic effects on a scale from 0 to 5
Grade 1 = mild in severity, Grade 0 = no severity)
Clinical test results within acceptable limits (hemoglobin >=9 grams per deciliter
Absolute neutrophil count >=1,500/microliter
Platelet count >=100,000/microliter
Serum creatinine <= upper limit of normal
Total bilirubin <= upper limit of normal
Total alkaline phosphatase <= 1.5 x upper limit of normal, or if exceeding this, then alkaline phosphatase liver fraction <= 1.5 x upper limit of normal
Aspartate transaminase (AST) and alanine transaminase (ALT) must be <=2.5 x upper limit of normal)
Male and female patients surgically sterile, abstinent, or practicing an effective method of birth control and female patients have a negative urine or serum pregnancy test result at screening

Exclusion Criteria:

Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent
Active viral hepatitis or chronic liver disease
Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled high blood pressure, or arrhythmias (irregular heartbeats)
Active infection
Female patient who is pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210665

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Show 25 Study Locations

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Sr. Director Clinical Research )
Study ID Numbers:	CR003583, SAR-3002, ET743SAR3002
Study First Received:	September 13, 2005
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00210665
Health Authority:	United States: Food and Drug Administration

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

standard care
safety
trabectedin
Soft tissue sarcoma
antitumor agent

Study placed in the following topic categories:

Ecteinascidin 743
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor

Sarcoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009