Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
This trial is active, not recruiting.
|Condition||sarcoma, soft tissue|
|Treatment||ifosfamide and doxorubicin vs gemcitabine and docetaxel|
|Sponsor||University of Michigan Cancer Center|
|Start date||August 2004|
|End date||April 2015|
|Trial size||80 participants|
|Trial identifier||NCT00189137, HUM 44800, UMCC 2004.010|
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.
|Intervention model||parallel assignment|
Explore relative activity and toxicity
time frame: 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.
time frame: 24 months
Male or female participants at least 10 years old.
Inclusion Criteria: - no evidence of metastasis - soft tissue sarcoma - intermediate or high histologic grade - greater than 5 cm - Zubrod performance status 1 or better - age 10 or older Exclusion Criteria: - clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's - prior chemotherapy - nephrectomy - active unstable angina pectoris - concurrent therapy
|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|
|Principal investigator||Scott Schuetze, MD, PhD|
|Description||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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