Leiomyosarcoma Clinical Trial
Official title:
Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
This is an open label single site Phase II clinical trial to identify a potentially
promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily
on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either
disease progression or cumulative/acute toxicity.
All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma,
liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt
Cancer Center will be screened for eligibility to be enrolled in the study.
This is an open label single site Phase II clinical trial to identify a potentially
promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug
will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be
continued until there is either disease progression or cumulative/acute toxicity which in
the opinion of the treating physician or the trial Principal Investigator (PI) compromises
the ability of the patient to receive treatment or the patient desires to stop treatment.
All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma,
and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in
the study.
An office visit will be required before the beginning of every cycle every 6 weeks to assess
toxicity and for physical examination. Complete blood count (CBC) and differential,
comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every
scheduled visit.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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