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Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Neoplasms, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female

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Trial Information

Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with objective response

Outcome Time Frame:

Up to approximately 3 years

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

September 2005

Related Keywords:

  • Ovarian Neoplasms
  • Endocrine Gland Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Ovarian Diseases
  • Adnexal Diseases
  • Genital Diseases, Female
  • Ovarian cancer
  • Ovary
  • Cancer
  • Trabectedin
  • Yondelis
  • ET743
  • Ecteinascidin 743
  • Antineoplastic Agents, Alkylating
  • Alkylating Agents
  • Adnexal Diseases
  • Neoplasms
  • Endocrine Gland Neoplasms
  • Genital Diseases, Female
  • Neoplasms by Site
  • Ovarian Neoplasms
  • Ovarian Diseases