Adnexal Diseases, Endocrine Gland Neoplasms, Genital Diseases, Female, Neoplasms, Neoplasms by Site, Ovarian Diseases, Ovarian Neoplasms
Conditions
Keywords
Ovarian cancer, Ovary, Cancer, Trabectedin, Yondelis, ET743, Ecteinascidin 743, Antineoplastic Agents, Alkylating, Alkylating Agents
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.
Interventions
DRUGTrabectedin
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.
DRUGDexamethasone
Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
Sponsors
PharmaMar
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with objective response | Up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Up to approximately 3 years |
| Time to progression | Up to approximately 3 years |
| Overall survival | Up to approximately 3 years |
| The number of patients with an unbiased objective 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 |
| Duration of response | Up to approximately 3 years |
Outcome results
None listed