A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Neoplasms Clinical Trial

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

Status Completed

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.

Clinical Trial 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

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

Related Conditions & MeSH terms

• Adnexal Diseases
• Endocrine Gland Neoplasms
• Genital Diseases, Female
• Neoplasms
• Neoplasms by Site
• Ovarian Diseases
• Ovarian Neoplasms

• NCT number: NCT00050414
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 2
• Start date: October 2002
• Completion date: September 2005