A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Trabectedin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trabectedin<br>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<br>* 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.<br>Drug: Dexamethasone<br>* Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with objective response |  | Up to approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trabectedin, Ovarian cancer, Ovary, Cancer, Yondelis, ET743, Ecteinascidin 743, Antineoplastic Agents, Alkylating, Alkylating Agents