NCT00061984

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

Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy. * Compare the response in patients treated with these regimens. * Compare the treatment-related mortality of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3). * Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Conditions

• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	pegfilgrastim
DRUG	doxorubicin hydrochloride
DRUG	ifosfamide
PROCEDURE	multimodality therapy

Timeline

• Start date: 2003-04-01
• Primary completion: 2010-05-01
• Completion: 2012-07-01
• First posted: 2003-06-06
• Last updated: 2014-10-27

Locations

41 sites across 11 countries: Austria, Belgium, Canada, Denmark, France, Germany, Netherlands, Slovakia, Spain, Switzerland, United Kingdom