A Study of Trabectedin in Patients With Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: Antineoplastic Agents, Alkylating; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Trabectedin

Criteria

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.