Clinical trial NCT00050414: A Study of Trabectedin in Patients With Advanced Ovarian Cancer
Official title: Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Keywords: Ovarian cancer
Ovary
Cancer
Trabectedin
Yondelis
ET743
Ecteinascidin 743
Antineoplastic Agents, Alkylating
Alkylating Agents
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2002-12-10
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with objective response
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: The number of patients with an unbiased objective response
timeFrame: Up to approximately 3 years
measure: Progression-free survival
timeFrame: Up to approximately 3 years
measure: Time to progression
timeFrame: Up to approximately 3 years
measure: Overall survival
timeFrame: Up to approximately 3 years
measure: Duration of response
timeFrame: Up to approximately 3 years
measure: Duration of stable disease
timeFrame: Up to approximately 3 years
measure: Cancer antigen 125 (CA125) response
timeFrame: Up to approximately 3 years
measure: The number of patients with adverse events
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: