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 CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Procedure: chemotherapy  Drug: CP4071	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma. II. Determine the clinical toxic effects of this drug in these patients.

PROTOCOL OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically or cytologically confirmed soft tissue sarcoma

• Metastatic or locally advanced
• Failed at least 1 prior therapy

Measurable disease outside prior irradiation field

No CNS metastases

--Prior/Concurrent Therapy--

Biologic therapy: Prior biologic response modifier therapy allowed

Chemotherapy:

• No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
• No other concurrent chemotherapy

Endocrine therapy: No concurrent hormonal therapy for malignancy

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery: At least 4 weeks since prior surgery and recovered

Other: No other concurrent cardiac glycosides

--Patient Characteristics--

Age: 18 and over

Performance status: SWOG 0-2

Life expectancy: Not specified

Hematopoietic: Not specified

Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

• Creatinine less than 1.5 times ULN
• Calcium less than ULN Potassium normal

Other:

• No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer
• Not pregnant or nursing
• Fertile patients must use effective contraception

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Robert N. Taub,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068689; CPMC-IRB-9825; NCI-G01-1952
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017446
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08