A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Leiomyosarcoma; Liposarcoma

Treatments: Drug: Dexamethasone; Drug: Yondelis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00060944

ET743-STS-201 (Other Identifier)

CR004336

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Full description

This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
• Have a pathology specimen available for centralized review
• Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
• Have adequate bone marrow, liver and kidney function
• Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

• Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
• Cancer that has metastasized (spread) to the central nervous system
• Active viral hepatitis or chronic liver disease
• Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
• History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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271 participants in 2 patient groups

Yondelis weekly schedule

Experimental group

Description:

Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Yondelis

Drug: Yondelis

Yondelis once every 3 weeks schedule

Experimental group

Description:

Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Yondelis

Drug: Yondelis