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SarcomaPhase 2NCT00005974

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

A Phase 2 study testing alvocidib in people with Sarcoma, run by NCIC Clinical Trials Group at 61 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Sarcoma
What is being tested?
alvocidib
Type of treatment
Injection or infusion
How many people
18 participants
Where
61 sitesin 2 countries
Study dates
4 Jul 2000to 22 Sep 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

Canada60 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Burnaby Hospital Regional Cancer Centre

    Burnaby, British Columbia, V5H 4C2

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Centre Universitaire de Sante de l'Estrie - Site Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton and Disrict Urology Association

    Hamilton, Ontario, L8N 1T8

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • Lethbridge Cancer Clinic

    Lethbridge, Alberta, T1J 1W5

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7T3

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite' de Montreal

    Montreal, Quebec, H2W 1T8

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Nanaimo Cancer Clinic

    Nanaimo, British Columbia, V9S 2B7

  • York County Hospital

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, V7L 2P9

  • North York General Hospital, Ontario

    North York, Ontario, M2E 1K1

  • Male Health Centre/CMX Research Inc.

    Oakville, Ontario, L6H 3PI

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Kells Medical Research Group Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrament, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Centre Hospitalier Regional de Rimouski

    Rimouski, Quebec, G5L 5T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Scarborough Hospital - General Site

    Scarborough Village, Ontario, M1P 2V5

  • Hotel Dieu Hospital - St. Catharines

    St. Catharines, Ontario, L2R 5K3

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Campus, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • St. Paul's Hospital - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • Capital Health Region (Endeavor Clinical Research)

    Victoria, British Columbia, V8V 3N1

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

United States1 site

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota, 55805

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Sarcoma
Being tested
alvocidib
Keywords
stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alvocidibDrug

    Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    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.

    Measured: 2 years

Secondary outcomes (1)

  1. Toxicity

    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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2004 (estimated)
  2. Study start4 Jul 2000
  3. Primary completion7 Nov 2002
  4. Study completion22 Sep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005974
Sponsor's protocol ID
I136
Other IDs
CAN-NCIC-IND136, NCI-NCIC-136, CDR0000067961
Status last verified
Apr 2020
First submitted
5 Jul 2000
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17251659

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvocidib in people with Sarcoma, run by NCIC Clinical Trials Group at 61 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.

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