A Study of Trabectedin in Patients With Advanced Ovarian Cancer

NCT00050414CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

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

Enrollment

147

Start Date

2002-10-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

TrabectedinDexamethasone

Conditions

Ovarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital DiseasesFemale

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Number of patients with objective response

Time frame: Up to approximately 3 years

Secondary Outcomes

The number of patients with an unbiased objective response

Time frame: Up to approximately 3 years

Progression-free survival

Time frame: Up to approximately 3 years

Time to progression

Time frame: Up to approximately 3 years

Overall survival

Time frame: Up to approximately 3 years

Duration of response

Time frame: Up to approximately 3 years

Duration of stable disease

Time frame: Up to approximately 3 years

Cancer antigen 125 (CA125) response

Time frame: Up to approximately 3 years

The number of patients with adverse events

Time frame: Up to approximately 3 years

A Study of Trabectedin in Patients With Advanced Ovarian Cancer