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)
Nanaimo Cancer Clinic
🇨🇦Nanaimo, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. Johns, Newfoundland and Labrador, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Hamilton and Disrict Urology Association
🇨🇦Hamilton, Ontario, Canada
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Hotel Dieu Hospital - St. Catharines
🇨🇦St. Catharines, Ontario, Canada
North York General Hospital, Ontario
🇨🇦North York, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
🇨🇦Quebec City, Quebec, Canada
Centre Hospitalier Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Capital Health Region (Endeavor Clinical Research)
🇨🇦Victoria, British Columbia, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
York County Hospital
🇨🇦Newmarket, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Centre Hospitalier de l'Universite' de Montreal
🇨🇦Montreal, Quebec, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Male Health Centre/CMX Research Inc.
🇨🇦Oakville, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
🇨🇦Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Centre Hospitalier Regional de Lanaudiere
🇨🇦Joliette, Quebec, Canada
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Kells Medical Research Group Inc.
🇨🇦Pointe Claire, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Lions Gate Hospital
🇨🇦North Vancouver, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
Scarborough Hospital - General Site
🇨🇦Scarborough, Ontario, Canada