A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00060944

Purpose

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Condition	Intervention	Phase
Liposarcoma Leiomyosarcoma Neoplasms, Connective and Soft Tissue Neoplasms, Adipose Tissue Neoplasms, Muscle Tissue Neoplasms by Histologic Type Sarcoma	Drug: Yondelis once every 3 weeks schedule Drug: Yondelis i.v. weekly schedule	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ecteinascidin 743 Dexamethasone Sodium Phosphate Ifosfamide

U.S. FDA Resources

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

Primary Outcome Measures:

Time to disease progression (or death due to progressive disease) [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Plasma (blood) concentration of Yondelis [ Time Frame: Up to 2 cycles (2 months) ] [ Designated as safety issue: No ]
Type and number of adverse events [ Time Frame: Up to 30 days from the date of last dministration of study drug ] [ Designated as safety issue: No ]

Enrollment:	271
Study Start Date:	May 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 Yondelis i.v. weekly schedule 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.	Drug: Yondelis i.v. weekly schedule 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.
Experimental: 002 Yondelis once every 3 weeks schedule 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.	Drug: Yondelis once every 3 weeks schedule 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle, 30 minutes prior to each infusion.

Detailed Description:

This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Eligibility

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

Criteria

Inclusion Criteria:

Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
Have a pathology specimen available for centralized review
Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
Have adequate bone marrow, liver and kidney function
Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
Cancer that has metastasized (spread) to the central nervous system
Active viral hepatitis or chronic liver disease
Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060944

Sponsors and Collaborators

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

PharmaMar

Investigators

Study Director:

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

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

More Information

No publications provided

Responsible Party:	Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00060944 History of Changes
Other Study ID Numbers:	CR004336, ET743-STS-201
Study First Received:	May 16, 2003
Last Updated:	August 12, 2011
Health Authority:	United States: Food and Drug Administration

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

Trabectedin
Yondelis
ET-743
Ecteinascidin
Anthracycline
Ifosfamide
Dexamethasone

Intravenous
Cancer
Malignant
Tumor
Advanced
Metastatic

Additional relevant MeSH terms:

Neoplasms
Leiomyosarcoma
Liposarcoma
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Muscle Neoplasms
Sarcoma
Soft Tissue Neoplasms
Neoplasms by Site
Muscular Diseases
Musculoskeletal Diseases
Dexamethasone acetate
Dexamethasone

Dexamethasone 21-phosphate
Trabectedin
Ifosfamide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on February 09, 2012