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

Endometrial Neoplasms Clinical Trial

Official title:

A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050440
• Other study ID #: CR004429
• Secondary ID: ET743-USA-1
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2002
• Last updated: January 7, 2013
• Start date: July 2002
• Est. completion date: July 2004

Study information

• Verified date: January 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01328314

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Genital Neoplasms, Female
• Genital Neoplasms, Female Urogenital Neoplasms
• Neoplasms
• Urogenital Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PharmaMar

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with objective response		Up to approximately 3 years
Secondary	Overall survival (OS)		Up to approximately 3 years	No
Secondary	The number of patients with adverse events		Up to approximately 3 years	No
Secondary	Time to progression (TTP)		Up to approximately 3 years	No
Secondary	Progression free survival (PFS),		Up to approximately 3 years	No

External Links

•   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.