Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over		CAN-NCIC-IND136 NCI-NCIC-136, NCT00005974, NCIC-136, IND136

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.

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

Expected Enrollment

A total of 15-30 patients will be accrued for this study over 12-18 months.

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.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Donald Morris, MD, PhD, FRCPC, Protocol chair		Ph: 403-521-3166

Registry Information
Official Title		A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients with Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
Trial Start Date		2000-07-04
Registered in ClinicalTrials.gov		NCT00005974
Date Submitted to PDQ		2000-05-10
Information Last Verified		2001-05-01
NCI Grant/Contract Number		R24-CA77202

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