Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma
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:
NCT00050440
First received: December 9, 2002
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Drug: Trabectedin Drug: Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma |
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 ]
Secondary Outcome Measures:
- Overall survival (OS) [ 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 ]
- Time to progression (TTP) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
- Progression free survival (PFS), [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | July 2002 |
| Study Completion Date: | July 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.
|
Drug: Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
Drug: Dexamethasone
Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose
|
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. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of advanced or metastatic endometrial carcinoma
- Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Performance status ECOG 0 or 1
Exclusion Criteria:
- Prior exposure to trabectedin
- Known hypersensitivity to dexamethasone or to any of the components of trabectedin
- Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
- History of another neoplastic disease unless in remission for more than 5 years
- Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
- Current pregnancy, lactation, or childbearing potential without adequate method of contraception.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050440
Locations
| United States, California | |
| Los Angeles, California, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| United States, Kentucky | |
| Lexington, Kentucky, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Canada, Ontario | |
| Toronto, Ontario, Canada | |
| Netherlands | |
| Maastricht, Netherlands | |
| Russian Federation | |
| Moscow, Russian Federation | |
| Moscow N/A, Russian Federation | |
| Obninsk N/A, Russian Federation | |
| St, Russian Federation | |
| St Petersburg, Russian Federation | |
| St Petersburg N/A, Russian Federation | |
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: | NCT00050440 History of Changes |
| Obsolete Identifiers: | NCT01328314 |
| Other Study ID Numbers: | CR004429, ET743-USA-1 |
| Study First Received: | December 9, 2002 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Endometrial Cancer Carcinoma Trabectedin Ecteinascidin 743 |
ET743 Antineoplastic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Endometrial Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site Uterine Diseases Genital Diseases, Female Trabectedin Antineoplastic Agents Dexamethasone |
Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Molecular Mechanisms of Pharmacological Action 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 |
ClinicalTrials.gov processed this record on June 17, 2013