A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00050414

Collaborator

PharmaMar (Industry)

147

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Oct 1, 2002

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

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.

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

Primary Outcome Measures

Number of patients with objective response [Up to approximately 3 years]

Secondary Outcome Measures

The number of patients with an unbiased objective response [Up to approximately 3 years]
Progression-free survival [Up to approximately 3 years]
Time to progression [Up to approximately 3 years]
Overall survival [Up to approximately 3 years]
Duration of response [Up to approximately 3 years]
Duration of stable disease [Up to approximately 3 years]
Cancer antigen 125 (CA125) response [Up to approximately 3 years]
The number of patients with adverse events [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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.