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A Study of Trabectedin in Patients With Advanced Ovarian Cancer
This study has been completed.

First Received on December 9, 2002.   Last Updated on April 26, 2011   History of Changes
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: NCT00050414
  Purpose

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.


Condition Intervention Phase
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Drug: Trabectedin
Phase II

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of patients with objective response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients with an unbiased objective response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of stable disease [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Cancer antigen 125 (CA125) response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • The number of patients with adverse events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2002
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: 001
Trabectedin 0.58 mg/m2 3-hour i.v. infusion Days 1 8 and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
Drug: Trabectedin
0.58 mg/m2, 3-hour i.v. infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.

Detailed Description:

Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of advanced epithelial ovarian cancer
  • Progression or recurrence during or after platinum-containing regimen
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
  • Pregnant or lactating women
  • Known metastases (spread) of cancer to the central nervous system
  • 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: NCT00050414

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: NCT00050414     History of Changes
Obsolete Identifiers: NCT01336504
Other Study ID Numbers: CR004057, ET743-INT-11
Study First Received: December 9, 2002
Last Updated: April 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Ovarian cancer
Ovary
Cancer
Trabectedin
Yondelis
ET743
Ecteinascidin 743
Antineoplastic Agents, Alkylating
Alkylating Agents

Additional relevant MeSH terms:
Adnexal Diseases
Neoplasms
Endocrine Gland Neoplasms
Genital Diseases, Female
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Endocrine System Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Trabectedin
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012