Leiomyosarcoma Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 271 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PharmaMar |
United States, Australia, Belgium, Canada, France, Germany, Russian Federation, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Progression- Independent Review | Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | Yes |
Secondary | Percentage of Participants Objective Response - Independent Review | Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | No |
Secondary | Duration of Response - Independent Review | Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | No |
Secondary | Progression-Free Survival - Independent Review | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | No |
Secondary | Overall Survival | The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. | From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years | No |
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