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.
- 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.
- 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
- 18 and over
- SWOG 0-2
- Not specified
- Not specified
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Creatinine less than 1.5 times ULN
- Calcium less than ULN
- Potassium normal
- 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
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Prior biologic response modifier therapy allowed
- No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic
- No other concurrent chemotherapy
- No concurrent hormonal therapy for malignancy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 4 weeks since prior surgery and recovered
- No other concurrent cardiac glycosides