CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

OBJECTIVES:

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

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.

• CP4071 (Drug)

Sex: All, ages: 18 Years to any

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

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

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

• Robert N. Taub, MD, PhD, Study chair, Herbert Irving Comprehensive Cancer Center