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



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

For Condition: stage 4B adult soft tissue sarcoma,recurrent adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Herbert Irving Comprehensive Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertTaub,  Study Chair,  Herbert Irving Comprehensive Cancer Center

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


Additional Information:
Study ID Numbers:  CDR0000068689;  NCI-G01-1952,CPMC-IRB-9825
Study Start Date: October 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017446

Other Stage 4b Adult Soft Tissue Sarcoma Studies:
1. Interferon alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma

2. Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

3. Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

4. Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

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

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