Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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.


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 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


NCT ID:

NCT00017446


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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