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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ifosfamide; Trabectedin

Criteria

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