Liposarcoma,Myxoid Clinical Trial
Official title:
A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
Status | Completed |
Enrollment | 29 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies - Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery - Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST]) - No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy) - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 Exclusion Criteria: - Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone - Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods - History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer - Known distant metastases - Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Pathological Complete Response (pCR) | Complete pathological response is complete disappearance of the tumor tissue up to the molecular level. | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | No |
Secondary | Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. | No |