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

NCT ID: NCT00050440

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2004-07-31

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.

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.

Conditions

Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female Urogenital Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

Trabectedin 1.3 mg/m2 administered intravenously every 21 days.

Dexamethasone

Intervention Type: DRUG

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

Interventions

Trabectedin

Trabectedin 1.3 mg/m2 administered intravenously every 21 days.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Los Angeles, California, United States

Miami, Florida, United States

Lexington, Kentucky, United States

Baltimore, Maryland, United States

New York, New York, United States

Oklahoma City, Oklahoma, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Toronto, Ontario, Canada

Maastricht, , Netherlands

Moscow, , Russia

Obninsk, , Russia

Saint Petersburg, , Russia

Saint, , Russia

Countries

United States; Canada; Netherlands; Russia

Related Links

http://dx.doi.org/10.1016/j.ygyno.2009.04.034

McMeekin DS, Lisyanskaya A, Crispens M, et al. Single-agent trabectedin as second-line therapy of persistent or recurrent endometrial cancer: results of a multi-center phase II study. Gynecol Oncol. 2009;114(2):288-92.

Other Identifiers

ET743-USA-1

Identifier Type: OTHER

Identifier Source: secondary_id

CR004429

Identifier Type: -

Identifier Source: org_study_id

NCT01328314

Identifier Type: -

Identifier Source: nct_alias