A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Neoplasms Clinical Trial

Official title:

Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050414
• Other study ID #: CR004057
• Secondary ID: ET743-INT-11
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2002
• Last updated: January 9, 2013
• Start date: October 2002
• Est. completion date: September 2005

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 study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian 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. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

Other known NCT identifiers

• NCT01336504

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of advanced epithelial ovarian cancer

• Progression or recurrence during or after platinum-containing regimen

• At least one measureable tumor lesion

• Adequate bone marrow, hepatic and renal function

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

• Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone

• Pregnant or lactating women

• Known metastases (spread) of cancer to the central nervous system

• History of another neoplastic disease unless in remission for five years or more.

Study Design

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

Related Conditions & MeSH terms

• Adnexal Diseases
• Endocrine Gland Neoplasms
• Genital Diseases, Female
• Neoplasms
• Neoplasms by Site
• Ovarian Diseases
• Ovarian Neoplasms

Intervention

Drug:
• Trabectedin
Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.
• Dexamethasone
Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with objective response		Up to approximately 3 years	No
Secondary	The number of patients with an unbiased objective response		Up to approximately 3 years	No
Secondary	Progression-free survival		Up to approximately 3 years	No
Secondary	Time to progression		Up to approximately 3 years	No
Secondary	Overall survival		Up to approximately 3 years	No
Secondary	Duration of response		Up to approximately 3 years	No
Secondary	Duration of stable disease		Up to approximately 3 years	No
Secondary	Cancer antigen 125 (CA125) response		Up to approximately 3 years	No
Secondary	The number of patients with adverse events		Up to approximately 3 years	No

External Links

•   Krasner CN, McMeekin DS, Chan S, et al. A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. British Journal of Cancer. 2007:97:1618-24.