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Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma Clinical research trials and Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma. Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
For Condition: stage 4A adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,stage 4B adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , National Cancer Institute of Canada
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldMorris, Study Chair, National Cancer Institute of Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Burnaby Hospital Regional Cancer Centre
Burnaby, British Columbia, V5H 4C2
Canada
Capital Health Region (Endeavor Clinical Research)
Victoria, British Columbia, V8V 3N1
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2
Canada
Lions Gate Hospital
North Vancouver, , V7L 2P9
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, L8N 1T8
Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7T3
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
London Health Sciences Centre
London, Ontario, N6A 4G5
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Scarborough Hospital - General Site
Scarborough, Ontario, M1P 2V5
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, L2R 5K3
Canada
Dr. H. Bliss Murphy Cancer Centre
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI
Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
United States
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Additional Information:
Study ID Numbers: CDR0000067961; CAN-NCIC-IND136,NCI-NCIC-136
Study Start Date: July 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005974
Other Stage 3 Adult Soft Tissue Sarcoma Studies:
1. Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
2. Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
3. CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
4. Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
5. Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
Related Studies:
Other stage 3 adult soft tissue sarcoma Clinical Trials
Other Quebec Clinical Trials
Other Ste Foy Clinical Trials
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
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