A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms; Adnexal Diseases; Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Genital Diseases, Female; Ovarian Diseases

Treatments: Drug: Dexamethasone; Drug: Trabectedin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00050414

CR004057

ET743-INT-11 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 147 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

Trabectedin

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Drug: Trabectedin