Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00005974
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response Rate 2 years 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.
- Secondary Outcome Measures
Name Time Method Toxicity 2 years To assess the toxicity of flavopiridol in patients with untreated, metastatic or locally advanced soft tissue sarcoma, as well as time to progression and early progression rate (PD within first 6 weeks), and, if responses are observed, response duration
Trial Locations
- Locations (61)
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
Nanaimo Cancer Clinic
🇨🇦Nanaimo, British Columbia, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
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