A Study of Trabectedin in Patients With Advanced Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00050414 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : January 10, 2013
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female | Drug: Trabectedin Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 147 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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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. |
- Number of patients with objective response [ Time Frame: Up to approximately 3 years ]
- The number of patients with an unbiased objective response [ Time Frame: Up to approximately 3 years ]
- Progression-free survival [ Time Frame: Up to approximately 3 years ]
- Time to progression [ Time Frame: Up to approximately 3 years ]
- Overall survival [ Time Frame: Up to approximately 3 years ]
- Duration of response [ Time Frame: Up to approximately 3 years ]
- Duration of stable disease [ Time Frame: Up to approximately 3 years ]
- Cancer antigen 125 (CA125) response [ Time Frame: Up to approximately 3 years ]
- The number of patients with adverse events [ Time Frame: Up to approximately 3 years ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050414
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00050414 |
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 Key Record Dates |
Last Update Posted: | January 10, 2013 |
Last Verified: | January 2013 |
Ovarian cancer Ovary Cancer Trabectedin Yondelis |
ET743 Ecteinascidin 743 Antineoplastic Agents, Alkylating Alkylating Agents |
Neoplasms Ovarian Neoplasms Carcinoma, Ovarian Epithelial Neoplasms by Site Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Dexamethasone |
Trabectedin 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 Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |