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Sarcoma

Trabectedin for Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma (20051530)
A Multicenter, Open-label Single-arm Study of YONDELIS® (trabectedin) for Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment
Status Conditions Phase Study ID
Recruiting Sarcoma Phase III 20051530
NCT00210665
Summary

The objective of this study is to facilitate access to trabectedin for eligible previously treated subjects with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options for treatment of STS but who may benefit from treatment with trabectedin.


Investigator
Robin L. Jones, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged ≥18 years.
  • Unresectable advanced or metastatic histologically proven STS. Eligibility will include desmoplastic small round cell tumor, Ewing's sarcoma, and osteosarcoma.
  • Subjects must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment or intolerant to prior standard of care treatment with chemotherapy due to safety issues.
  • Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (NCI-CTCAE, Version 3).
  • Hematologic test results:
  • Hemoglobin ≥8 g/dL
  • Absolute neutrophil count (ANC) ≥1,500/μL
  • Platelet count ≥100,000/μL
  • Clinical chemistry test results:
  • If serum creatinine ≤1.5 times the upper limit of normal (ULN), or if serum creatinine is >1.5 times the ULN, then 24 hour creatinine clearance of >50 cc/min, creatine phosphokinase (CPK) ≤2.5 times the ULN
  • Hepatic function test results:
  • Total bilirubin ≤ULN, if increased then measure indirectly to rule out Gilbert's syndrome. If direct bilirubin is within normal limits, subject may be considered eligible.
  • Total alkaline phosphatase ≤1.5 times the ULN, or if liver metastases are present, then alkaline phosphatase may be ≤2.5 times the ULN.
  • AST and ALT must be ≤2.5 times the ULN.
  • Female subjects must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry and throughout the study, and have a negative urine or serum pregnancy test result at screening. For male subjects and partners, acceptable methods of birth control include sterilization, barrier contraception, and abstinence.
  • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Last Updated
August 20, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.