Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Sarcoma, Soft Tissue |
| Intervention | Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel |
| Phase | Phase 2 |
| Sponsor | University of Michigan Cancer Center |
| Responsible Party | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier | NCT00189137 |
| First Received | September 13, 2005 |
| Last Updated | April 4, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2005 |
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| Last Updated Date | April 4, 2013 |
| Start Date | August 2004 |
| Estimated Primary Completion Date | June 2015 |
| Current Primary Outcome Measures | 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.] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | Disease-free survival [Time Frame: 24 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma |
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| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Sarcoma, Soft Tissue |
| Intervention | Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. 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. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 80 |
| Estimated Completion Date | June 2015 |
| Estimated Primary Completion Date | April 2015 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00189137 |
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| Other Study ID Numbers | UMCC 2004.010 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Michigan Cancer Center |
| Study Sponsor | University of Michigan Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Scott Schuetze, MD, PhD University of Michigan Cancer Center |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, United States, 48109 |
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