A Study of Trabectedin in Patients With Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00050414
First received: December 9, 2002
Last updated: January 9, 2013
Last verified: January 2013
  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
Drug: Dexamethasone
Phase 2

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: 147
Study Start Date: October 2002
Study Completion Date: September 2005
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & 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: January 9, 2013
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:
Ovarian Neoplasms
Neoplasms
Neoplasms by Site
Genital Diseases, Female
Ovarian Diseases
Endocrine Gland Neoplasms
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Trabectedin
BB 1101
Antineoplastic Agents, Alkylating
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014