A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
18 Years
N/A
Both
Liposarcoma, Leiomyosarcoma, Neoplasms, Connective and Soft Tissue, Neoplasms, Adipose Tissue, Neoplasms, Muscle Tissue, Neoplasms by Histologic Type, Sarcoma
Trial Information
A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to disease progression (or death due to progressive disease)
Outcome Time Frame:
Up to 30 months
Safety Issue:
No
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR004336
NCT ID:
NCT00060944
Start Date:
April 2003
Completion Date:
May 2008
Related Keywords:
- Liposarcoma
- Leiomyosarcoma
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Adipose Tissue
- Neoplasms, Muscle Tissue
- Neoplasms by Histologic Type
- Sarcoma
- Trabectedin
- Yondelis
- ET-743
- Ecteinascidin
- Anthracycline
- Ifosfamide
- Dexamethasone
- Intravenous
- Cancer
- Malignant
- Tumor
- Advanced
- Metastatic
- Neoplasms
- Leiomyosarcoma
- Liposarcoma
- Neoplasms by Histologic Type
- Neoplasms, Muscle Tissue
- Neoplasms, Adipose Tissue
- Neoplasms, Connective and Soft Tissue
- Muscle Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Fountain Valley, California 92708 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Salt Lake City, Utah 84112 | |
| Coeur D'alene, Idaho 83814 |
