- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Vancouver, Canada, V7L 2P9
- Lions Gate Hospital
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Lethbridge, Alberta, Canada, T1J 1W5
- Lethbridge Cancer Clinic
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British Columbia
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Burnaby, British Columbia, Canada, V5H 4C2
- Burnaby Hospital Regional Cancer Centre
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Nanaimo, British Columbia, Canada, V9S 2B7
- Nanaimo Cancer Clinic
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Penticton, British Columbia, Canada, V2A 3G6
- Penticton Regional Hospital
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Surrey, British Columbia, Canada, V3V 1Z2
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
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Vancouver, British Columbia, Canada, V5Z 3J5
- Prostate Centre at Vancouver General Hospital
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital - Vancouver
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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Victoria, British Columbia, Canada, V8V 3N1
- Capital Health Region (Endeavor Clinical Research)
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6ZB
- Moncton Hospital
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Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Hospital, Barrie
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Brampton, Ontario, Canada, L6W 2Z8
- William Osler Health Centre
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Hamilton, Ontario, Canada, L8N 1T8
- Hamilton and Disrict Urology Association
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London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Markham, Ontario, Canada, L3P 7T3
- Markham Stouffville Hospital
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Mississauga, Ontario, Canada, L5B 1B8
- Trillium Health Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
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Newmarket, Ontario, Canada, L3Y 2P9
- York County Hospital
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North York, Ontario, Canada, M2E 1K1
- North York General Hospital, Ontario
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Oakville, Ontario, Canada, L6H 3PI
- Male Health Centre/CMX Research Inc.
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health Oshawa
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre - General Campus
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Peterborough, Ontario, Canada, K9H 7B6
- Peterborough Oncology Clinic
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Scarborough, Ontario, Canada, M1P 2V5
- Scarborough Hospital - General Site
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St. Catharines, Ontario, Canada, L2R 5K3
- Hotel Dieu Hospital - St. Catharines
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M4C 3E7
- Toronto East General Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital - Toronto
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital - Toronto
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Toronto, Ontario, Canada, M5S 1B6
- Women's College Campus, Sunnybrook and Women's College Health Science Center
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Toronto, Ontario, Canada, M6R 1B5
- Saint Joseph's Health Centre - Toronto
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Weston, Ontario, Canada, M9N 1N8
- Humber River Regional Hospital
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Windsor, Ontario, Canada, N8W 2X3
- Cancer Care Ontario - Windsor Regional Cancer Centre
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 8T5
- Queen Elizabeth Hospital, PEI
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- Centre Universitaire de Sante de l'Estrie - Site Fleurimont
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hopital Charles Lemoyne
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Joliette, Quebec, Canada, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Montreal, Quebec, Canada, H2W 1T8
- Centre Hospitalier de l'Universite' de Montreal
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Montreal, Quebec, Canada, H4J 1C5
- Hopital du Sacre-Coeur de Montreal
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Department of Oncology
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Pointe Claire, Quebec, Canada, H9R 4S3
- Kells Medical Research Group Inc.
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Quebec City, Quebec, Canada, G1S 4L8
- Hopital du Saint-Sacrament, Quebec
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
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Rimouski, Quebec, Canada, G5L 5T1
- Centre Hospitalier Regional De Rimouski
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Ste-Foy, Quebec, Canada, G1V 4G5
- L'Hopital Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Minnesota
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Duluth, Minnesota, United States, 55805
- St. Mary's/Duluth Clinic Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed previously untreated metastatic or locally advanced soft tissue sarcoma not amenable to standard curative therapies Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Bone lesions are not considered measurable Must have measurable disease outside irradiated area unless evidence of progression or new lesions inside irradiated area No carcinosarcoma, Kaposi's sarcoma, soft tissue Ewing's sarcoma, or embryonal rhabdomyosarcoma
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 2 years
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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.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: 2 years
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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
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Donald G. Morris, MD, PhD, FRCPC, Tom Baker Cancer Centre - Calgary
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I136
- CAN-NCIC-IND136 (OTHER: PDQ)
- NCI-NCIC-136 (OTHER: NCI)
- CDR0000067961 (OTHER: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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