Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00005974
Last Updated: 2020-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2000-07-04
2008-09-22
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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alvocidib
Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: If history of cardiac disease, cardiac ejection function greater than 50% No clinically significant cardiac symptomatology Pulmonary: If history of symptomatic pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted No clinically significant pulmonary symptomatology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation Chemotherapy: No prior chemotherapy for metastatic or locally advanced disease No prior high dose chemotherapy and stem cell transplantation Prior adjuvant chemotherapy allowed At least 6 months since prior chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 25% of functioning bone marrow irradiated No concurrent radiotherapy to sole site of measurable disease Surgery: At least 4 weeks since prior major surgery Other: No other concurrent anticancer therapy
18 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Donald G. Morris, MD, PhD, FRCPC
Role: STUDY_CHAIR
Tom Baker Cancer Centre - Calgary
Locations
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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
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
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
York County Hospital
Newmarket, Ontario, Canada
North York General Hospital, Ontario
North York, Ontario, Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Québec, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Lions Gate Hospital
North Vancouver, , Canada
Countries
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References
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Morris DG, Bramwell VH, Turcotte R, Figueredo AT, Blackstein ME, Verma S, Matthews S, Eisenhauer EA. A Phase II Study of Flavopiridol in Patients With Previously Untreated Advanced Soft Tissue Sarcoma. Sarcoma. 2006;2006:64374. doi: 10.1155/SRCM/2006/64374.
Other Identifiers
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CAN-NCIC-IND136
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-NCIC-136
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067961
Identifier Type: OTHER
Identifier Source: secondary_id
I136
Identifier Type: -
Identifier Source: org_study_id
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