Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma

NCIC Clinical Trials Group (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Actual Enrollment :
18 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
Actual Study Start Date :
Jul 4, 2000
Actual Primary Completion Date :
Nov 7, 2002
Actual Study Completion Date :
Sep 22, 2008

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:

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

Contacts and Locations


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

Sponsors and Collaborators

  • NCIC Clinical Trials Group


  • Study Chair: Donald G. Morris, MD, PhD, FRCPC, Tom Baker Cancer Centre - Calgary

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • I136
  • NCI-NCIC-136
  • CDR0000067961
First Posted:
May 3, 2004
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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.:
Keywords provided by NCIC Clinical Trials Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2020