An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Trabectedin; Drug: DOXIL; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113607

2004-005276-16 (EudraCT Number)

CR003448

ET743-OVA-301 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Full description

This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms (DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety will be evaluated on the basis of adverse events, clinical laboratory tests, physical examination, vital signs assessment and cardiovascular safety assessment. An interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study. Treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles. Continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment, is eligible to receive further therapy, and consents to treatment. If disease progression has not occurred at treatment termination, then disease assessment will continue every 8 weeks until there is evidence of disease progression or death, or until the clinical data cutoff date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Enrollment: 672 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
• Prior treatment with only 1 platinum based chemotherapy regimen
• Eastern Cooperative Oncology Group status of not more than 2
• Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion criteria

• Treatment with more than 1 prior chemotherapy regimen
• Progression within 6 months after starting initial chemotherapy
• Prior exposure to anthracyclines
• Unwilling or unable to have central venous catheter
• Known clinically relevant central nervous system metastasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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672 participants in 2 patient groups

DOXIL + trabectedin

Experimental group

Description:

Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.

Treatment:

Drug: DOXIL

Drug: Dexamethasone

Drug: Trabectedin

DOXIL

Active Comparator group

Description:

Monotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.

Treatment:

Drug: DOXIL