NCT00005974

Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.

Detailed description

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 months.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	alvocidib	Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks

Timeline

• Start date: 2000-07-04
• Primary completion: 2002-11-07
• Completion: 2008-09-22
• First posted: 2004-05-03
• Last updated: 2020-04-08

Locations

61 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study