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A Study of Trabectedin in Patients With Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050414
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Drug: Trabectedin Drug: Dexamethasone Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
Study Start Date : October 2002
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Trabectedin
Trabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
 Drug: Trabectedin
Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.

Drug: Dexamethasone
Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with objective response [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. The number of patients with an unbiased objective response [ Time Frame: Up to approximately 3 years ]
  2. Progression-free survival [ Time Frame: Up to approximately 3 years ]
  3. Time to progression [ Time Frame: Up to approximately 3 years ]
  4. Overall survival [ Time Frame: Up to approximately 3 years ]
  5. Duration of response [ Time Frame: Up to approximately 3 years ]
  6. Duration of stable disease [ Time Frame: Up to approximately 3 years ]
  7. Cancer antigen 125 (CA125) response [ Time Frame: Up to approximately 3 years ]
  8. The number of patients with adverse events [ Time Frame: Up to approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050414


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Additional Information:

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050414    
Obsolete Identifiers: NCT01336504
Other Study ID Numbers: CR004057
ET743-INT-11 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
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:
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Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms by Site
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Dexamethasone
 Trabectedin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action