Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
- Conditions
- Sarcoma, Soft Tissue
- Interventions
- Registration Number
- NCT00189137
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
- prior chemotherapy
- nephrectomy
- active unstable angina pectoris
- concurrent therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description doxorubicin and ifosfamide ifosfamide and doxorubicin vs gemcitabine and docetaxel - gemcitabine and docetaxel ifosfamide and doxorubicin vs gemcitabine and docetaxel -
- Primary Outcome Measures
Name Time Method Percentage of Patients Hospitalized in Each Arm. 12 weeks 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.
- Secondary Outcome Measures
Name Time Method The Percentage of Patients Alive Without Disease at 2 Years 2 years Disease-free survival
Trial Locations
- Locations (1)
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States