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 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Explore relative activity and toxicity
To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
Scott Schuetze, MD, PhD
University of Michigan Cancer Center
United States: Institutional Review Board
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|