Overview

This trial is active, not recruiting.

Condition sarcoma, soft tissue
Treatment ifosfamide and doxorubicin vs gemcitabine and docetaxel
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
(Experimental)
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Disease-free survival
time frame: 24 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.