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A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

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

Inclusion 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Donald G. Morris, MD, PhD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Tom Baker Cancer Centre - Calgary


Canada: Health Canada

Study ID:




Start Date:

July 2000

Completion Date:

September 2008

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma



St. Mary's/Duluth Clinic Health System Duluth, Minnesota  55805