A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female	Drug: Trabectedin; Drug: Dexamethasone	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	147 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
Study Start Date :	October 2002
Actual Study Completion Date :	September 2005

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.	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.

Outcome Measures

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Primary Outcome Measures :

1. Number of patients with objective response [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :

1. The number of patients with an unbiased objective response [ Time Frame: Up to approximately 3 years ]
2. Progression-free survival [ Time Frame: Up to approximately 3 years ]
3. Time to progression [ Time Frame: Up to approximately 3 years ]
4. Overall survival [ Time Frame: Up to approximately 3 years ]
5. Duration of response [ Time Frame: Up to approximately 3 years ]
6. Duration of stable disease [ Time Frame: Up to approximately 3 years ]
7. Cancer antigen 125 (CA125) response [ Time Frame: Up to approximately 3 years ]
8. The number of patients with adverse events [ Time Frame: Up to approximately 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PharmaMar

Investigators

Study Director:	Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Krasner CN, McMeekin DS, Chan S, et al. A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. British Journal of Cancer. 2007:97:1618-24. 

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00050414 History of Changes
Obsolete Identifiers:	NCT01336504
Other Study ID Numbers:	CR004057; ET743-INT-11 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted:	December 10, 2002
Last Update Posted:	January 10, 2013
Last Verified:	January 2013

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Ovarian cancer; Ovary; Cancer; Trabectedin; Yondelis	ET743; Ecteinascidin 743; Antineoplastic Agents, Alkylating; Alkylating Agents

Additional relevant MeSH terms:

Neoplasms; Ovarian Neoplasms; Neoplasms by Site; Ovarian Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Dexamethasone acetate; Dexamethasone; Trabectedin; BB 1101

Antineoplastic Agents, Alkylating; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action