A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
18 Years
N/A
Female
Endometrial Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female Urogenital Neoplasms
Trial Information
A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients with objective response
Outcome Time Frame:
Up to approximately 3 years
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR004429
NCT ID:
NCT00050440
Start Date:
July 2002
Completion Date:
July 2004
Related Keywords:
- Endometrial Neoplasms
- Uterine Neoplasms
- Genital Neoplasms, Female Urogenital Neoplasms
- Endometrial
- Cancer
- Carcinoma
- Trabectedin
- Ecteinascidin 743
- ET743
- Antineoplastic Agents
- Alkylating Agents
- Molecular Mechanisms of Pharmacological Action
- Neoplasms
- Carcinoma
- Endometrial Neoplasms
- Genital Neoplasms, Female
- Urogenital Neoplasms
- Uterine Neoplasms
- Adenoma
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Louisville, Kentucky 40207 | |
| Baltimore, Maryland 21287 | |
| Tulsa, Oklahoma |
