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

This study has been completed.
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) Identifier:
First received: July 5, 2000
Last updated: September 27, 2011
Last verified: September 2011

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 Intervention Phase
Sarcoma Drug: alvocidib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

Resource links provided by NLM:

Further study details as provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):

Primary Outcome Measures:
  • Response Rate [ Time Frame: 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:
  • Toxicity [ Time Frame: 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

Enrollment: 18
Study Start Date: July 2000
Study Completion Date: September 2008
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alvocidib
    Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00005974

  Show 61 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Study Chair: Donald G. Morris, MD, PhD, FRCPC Tom Baker Cancer Centre - Calgary
  More Information

Responsible Party: NCIC Clinical Trials Group Identifier: NCT00005974     History of Changes
Other Study ID Numbers: I136
CDR0000067961 ( Other Identifier: PDQ )
Study First Received: July 5, 2000
Last Updated: September 27, 2011

Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017