Trials / Completed
CompletedNCT00050414
A Study of Trabectedin in Patients With Advanced Ovarian Cancer
Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.
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.
Conditions
- Ovarian Neoplasms
- Endocrine Gland Neoplasms
- Neoplasms by Site
- Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Diseases, Female
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2002-10-01
- Completion
- 2005-09-01
- First posted
- 2002-12-10
- Last updated
- 2013-01-10
Source: ClinicalTrials.gov record NCT00050414. Inclusion in this directory is not an endorsement.