CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
This trial is active, not recruiting.
|Sponsor||Herbert Irving Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2000|
|Trial identifier||NCT00017446, CDR0000068689, CPMC-IRB-9825, NCI-G01-1952|
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.
Male or female participants at least 18 years old.
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
|Official title||Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas|
|Description||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.|
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