drugset / Trial / NCT00061984

Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

NCT00061984

RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.

Timeline

Start
2003-04
Primary completion
2010-05
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject Ifosfamide Small molecule 10 g Intravenous
Background Pegfilgrastim Protein / enzyme biologic Subcutaneous

Indications