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Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma

University of Michigan Rogel Cancer Center logo

University of Michigan Rogel Cancer Center

Status and phase

Completed
Phase 2

Conditions

Sarcoma, Soft Tissue

Treatments

Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00189137
HUM 44800 (Other Identifier)
UMCC 2004.010

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

doxorubicin and ifosfamide
Active Comparator group
Treatment:
Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel
gemcitabine and docetaxel
Experimental group
Treatment:
Drug: ifosfamide and doxorubicin vs gemcitabine and docetaxel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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