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Phase II Evaluation of Ifosfamide Plus Doxorubicin & Filgrastim Versus Gemcitabine Plus Docetaxel & Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma


Phase 2
10 Years
N/A
Open (Enrolling)
Both
Sarcoma, Soft Tissue

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Explore relative activity and toxicity

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Scott Schuetze, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2004.010

NCT ID:

NCT00189137

Start Date:

August 2004

Completion Date:

June 2015

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752