CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00017446
Last Updated: 2014-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2000-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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CP4071
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Herbert Irving Comprehensive Cancer Center
OTHER
Principal Investigators
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Robert N. Taub, MD, PhD
Role: STUDY_CHAIR
Herbert Irving Comprehensive Cancer Center
Locations
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Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CPMC-IRB-9825
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1952
Identifier Type: -
Identifier Source: secondary_id
CDR0000068689
Identifier Type: -
Identifier Source: org_study_id
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