Sarcoma, Soft Tissue Clinical Trial
Official title:
Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
The purpose of this study is to explore the relative activity and toxicity of a newer
combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard
combination of chemotherapy drugs, ifosfamide and doxorubicin.
Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for
some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug
Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung)
because patients with those cancers treated with either gemcitabine or docetaxel experienced
shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or
docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a
standard treatment for advanced sarcoma.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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N/A |