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.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Drug: flavopiridol	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

Minnesota
      St. Mary's/Duluth Clinic Health System, Duluth,  Minnesota,  55805,  United States
Canada
      Lions Gate Hospital, North Vancouver,  V7L 2P9,  Canada
Canada, Alberta
      Lethbridge Cancer Clinic, Lethbridge,  Alberta,  T1J 1W5,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, British Columbia
      BC Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada
      British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey,  British Columbia,  V3V 1Z2,  Canada
      Burnaby Hospital Regional Cancer Centre, Burnaby,  British Columbia,  V5H 4C2,  Canada
      Capital Health Region (Endeavor Clinical Research), Victoria,  British Columbia,  V8V 3N1,  Canada
      Nanaimo Cancer Clinic, Nanaimo,  British Columbia,  V9S 2B7,  Canada
      Penticton Regional Hospital, Penticton,  British Columbia,  V2A 3G6,  Canada
      Prostate Centre at Vancouver General Hospital, Vancouver,  British Columbia,  V5Z 3J5,  Canada
      St. Paul's Hospital - Vancouver, Vancouver,  British Columbia,  V6Z 1Y6,  Canada
Canada, New Brunswick
      Doctor Leon Richard Oncology Centre, Moncton,  New Brunswick,  E1C 8X3,  Canada
      Moncton Hospital, Moncton,  New Brunswick,  E1C 6ZB,  Canada
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada
Canada, Newfoundland and Labrador
      Dr. H. Bliss Murphy Cancer Centre, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Credit Valley Hospital, Mississauga,  Ontario,  L5M 2N1,  Canada
      Hamilton and Disrict Urology Association, Hamilton,  Ontario,  L8N 1T8,  Canada
      Hotel Dieu Hospital - St. Catharines, St. Catharines,  Ontario,  L2R 5K3,  Canada
      Humber River Regional Hospital, Weston,  Ontario,  M9N 1N8,  Canada
      Lakeridge Health Oshawa, Oshawa,  Ontario,  L1G 2B9,  Canada
      London Health Sciences Centre, London,  Ontario,  N6A 4G5,  Canada
      Male Health Centre/CMX Research Inc., Oakville,  Ontario,  L6H 3PI,  Canada
      Markham Stouffville Hospital, Markham,  Ontario,  L3P 7T3,  Canada
      Mount Sinai Hospital - Toronto, Toronto,  Ontario,  M5G 1X5,  Canada
      North York General Hospital, Ontario, North York,  Ontario,  M2E 1K1,  Canada
      Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury,  Ontario,  P3E 5J1,  Canada
      Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay,  Ontario,  P7A 7T1,  Canada
      Ottawa Regional Cancer Centre - General Campus, Ottawa,  Ontario,  K1H 1C4,  Canada
      Peterborough Oncology Clinic, Peterborough,  Ontario,  K9H 7B6,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
      Royal Victoria Hospital, Barrie, Barrie,  Ontario,  L4M 6M2,  Canada
      Saint Joseph's Health Centre - Toronto, Toronto,  Ontario,  M6R 1B5,  Canada
      Scarborough Hospital - General Site, Scarborough,  Ontario,  M1P 2V5,  Canada
      St. Michael's Hospital - Toronto, Toronto,  Ontario,  M5B 1W8,  Canada
      Toronto East General Hospital, Toronto,  Ontario,  M4C 3E7,  Canada
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
      Trillium Health Centre, Mississauga,  Ontario,  L5B 1B8,  Canada
      William Osler Health Centre, Brampton,  Ontario,  L6W 2Z8,  Canada
      Women's College Campus, Sunnybrook and Women's College Health Science Center, Toronto,  Ontario,  M5S 1B6,  Canada
      York County Hospital, Newmarket,  Ontario,  L3Y 2P9,  Canada
Canada, Prince Edward Island
      Queen Elizabeth Hospital, PEI, Charlottetown,  Prince Edward Island,  C1A 8T5,  Canada
Canada, Quebec
      Centre Hospitalier de l'Universite' de Montreal, Montreal,  Quebec,  H2W 1T8,  Canada
      Centre Hospitalier Regional de Lanaudiere, Joliette,  Quebec,  J6E 6J2,  Canada
      Centre Hospitalier Regional de Rimouski, Rimouski,  Quebec,  G5L 5T1,  Canada
      Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada
      Centre Universitaire de Sante de l'Estrie - Site Fleurimont, Fleurimont,  Quebec,  J1H 5N4,  Canada
      Hopital Charles Lemoyne, Greenfield Park,  Quebec,  J4V 2H1,  Canada
      Hopital Du Sacre-Coeur de Montreal, Montreal,  Quebec,  H4J 1C5,  Canada
      Hopital du Saint-Sacrament, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada
      Kells Medical Research Group Inc., Pointe-Claire,  Quebec,  H9R 4S3,  Canada
      L'Hopital Laval, Ste Foy,  Quebec,  G1V 4G5,  Canada
      Maisonneuve-Rosemont Hospital, Montreal,  Quebec,  H1T 2M4,  Canada
      McGill University Department of Oncology, Montreal,  Quebec,  H2W 1S6,  Canada
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada

Study chairs or principal investigators

Donald G. Morris,  Study Chair,  National Cancer Institute of Canada   

Study ID Numbers:  CDR0000067961; CAN-NCIC-IND136; NCI-NCIC-136
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005974
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08