Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00050440

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	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Ecteinascidin 743

U.S. FDA Resources

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:	September 2002
Study Completion Date:	July 2004

Arms	Assigned Interventions
Experimental: 001 Trabectedin Trabectedin 1.3 mg/m2 i.v. every 21 days. Dexamethasone will be administered at 4 mg p.o. the day before trabectedin 20 mg i.v. 30 minutes before trabectedin and 4 mg p.o. for 2 days following trabectedin	Drug: Trabectedin Trabectedin 1.3 mg/m2 i.v. every 21 days. Dexamethasone will be administered at 4 mg p.o. the day before trabectedin, 20 mg i.v. 30 minutes before trabectedin, and 4 mg p.o. for 2 days following trabectedin

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

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

No publications provided

Responsible Party:	Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and 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:	April 26, 2011
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site

Uterine Diseases
Genital Diseases, Female
Trabectedin
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2012