A Study of Trabectedin in Patients With Advanced Ovarian Cancer
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00050414
First received: December 9, 2002
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- Number of patients with objective response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of patients with an unbiased objective response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Duration of stable disease [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Cancer antigen 125 (CA125) response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- The number of patients with adverse events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 147 |
| Study Start Date: | October 2002 |
| Study Completion Date: | September 2005 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050414
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
Additional Information:
No publications provided
| 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 |
| Study First Received: | December 9, 2002 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
Adnexal Diseases Neoplasms Endocrine Gland Neoplasms Genital Diseases, Female Neoplasms by Site Ovarian Neoplasms Ovarian Diseases Endocrine System Diseases Genital Neoplasms, Female Urogenital Neoplasms Gonadal Disorders Trabectedin Antineoplastic Agents Dexamethasone Dexamethasone acetate |
Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents, Alkylating Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013