Neoplasms Clinical Trial
Official title:
A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.
Status | Completed |
Enrollment | 41 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have a diagnosis of soft tissue sarcoma, recurrent or persistent - Signed informed consent obtained for all patients before performing any study-related procedures Exclusion Criteria: - Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy) - Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin - Less than 4 weeks since radiation therapy - Known metastases (spread) of cancer to the central nervous system - Other ongoing serious illness present at the time of enrollment as determined by the Investigator |
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, PharmaMar S.A.U. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events as a measure of safety | Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up) | Yes | |
Secondary | The number of patients with clinically relevant changes in clinically laboratory tests | Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) | Yes | |
Secondary | Number of patients with neutropenia | Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up) | Yes | |
Secondary | Plasma concentrations of trabectedin (Yondelis) | During the first 3 weeks of treatment | No | |
Secondary | Plasma concentrations of Doxorubicin | During the first 3 weeks of treatment | No | |
Secondary | Plasma concentrations of Doxorubicinol | During the first 3 weeks of treatment | No |
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