A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
OBJECTIVES: I. Determine the efficacy of flavopiridol in terms of response rate in patients
with previously untreated metastatic or locally advanced soft tissue sarcoma. II. Determine
the toxicity of this regimen in these patients. III. Determine the time to progression,
early progression rate, and response duration in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily on
days 1-3. Treatment continues every 3 weeks in the absence of disease progression or
unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months until
disease progression or death.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-18
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the efficacy (response rate) of flavopiridol given as an N infusion daily x 3 days every 3 weeks in the patients with untreated, metastatic or locally advanced soft tissue sarcoma.
Donald G. Morris, MD, PhD, FRCPC
Tom Baker Cancer Centre - Calgary
Canada: Health Canada
|St. Mary's/Duluth Clinic Health System||Duluth, Minnesota 55805|