A Study of Trabectedin in Patients With Advanced Ovarian Cancer

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

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Neoplasms; Genital Diseases, Female
• Intervention / Treatment: Drug: Trabectedin; Drug: Dexamethasone

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.	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.; Drug: Dexamethasone; Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with objective response	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to approximately 3 years
Progression-free survival	Up to approximately 3 years
The number of patients with an unbiased objective response	Up to approximately 3 years
Time to progression	Up to approximately 3 years
Duration of response	Up to approximately 3 years
Duration of stable disease	Up to approximately 3 years
Cancer antigen 125 (CA125) response	Up to approximately 3 years
The number of patients with adverse events	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: PharmaMar

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: December 9, 2002
• First Submitted That Met QC Criteria: December 9, 2002
• First Posted (Estimate): December 10, 2002

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Cancer; Ovarian cancer; Ovary; Trabectedin; Yondelis; Ecteinascidin 743; Alkylating Agents; ET743; Antineoplastic Agents, Alkylating
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms by Site; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Dexamethasone; Trabectedin
• Other Study ID Numbers: CR004057; ET743-INT-11 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)