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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00050440

Collaborator

PharmaMar (Industry)

Enrollment

Locations

Arm

Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms	Drug: Trabectedin Drug: Dexamethasone	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2002

Actual Study Completion Date :

Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Number of patients with objective response [Up to approximately 3 years]

Secondary Outcome Measures

Overall survival (OS) [Up to approximately 3 years]
The number of patients with adverse events [Up to approximately 3 years]
Time to progression (TTP) [Up to approximately 3 years]
Progression free survival (PFS), [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Los Angeles	California	United States
2	Miami	Florida	United States
3	Lexington	Kentucky	United States
4	Baltimore	Maryland	United States
5	New York	New York	United States
6	Oklahoma City	Oklahoma	United States
7	Nashville	Tennessee	United States
8	Dallas	Texas	United States
9	Toronto	Ontario	Canada
10	Maastricht		Netherlands
11	Moscow N/A		Russian Federation
12	Moscow		Russian Federation
13	Obninsk N/A		Russian Federation
14	St Petersburg N/A		Russian Federation
15	St Petersburg		Russian Federation
16	St		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.