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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00050414
Other study ID # CR004057
Secondary ID ET743-INT-11
Status Completed
Phase Phase 2
First received December 9, 2002
Last updated January 9, 2013
Start date October 2002
Est. completion date September 2005

Study information

Verified date January 2013
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Other known NCT identifiers
  • NCT01336504

Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with objective response Up to approximately 3 years No
Secondary The number of patients with an unbiased objective response Up to approximately 3 years No
Secondary Progression-free survival Up to approximately 3 years No
Secondary Time to progression Up to approximately 3 years No
Secondary Overall survival Up to approximately 3 years No
Secondary Duration of response Up to approximately 3 years No
Secondary Duration of stable disease Up to approximately 3 years No
Secondary Cancer antigen 125 (CA125) response Up to approximately 3 years No
Secondary The number of patients with adverse events Up to approximately 3 years No
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