PS-341 in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00017329
Last Updated: 2009-12-15
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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COMPLETED
PHASE2
INTERVENTIONAL
2001-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
Detailed Description
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* Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
* Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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bortezomib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed renal cell carcinoma
* Metastatic disease
* Unidimensionally measurable disease
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT/AST no greater than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* No pre-existing neuropathy of grade 1 or greater
* No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy and recovered
* No concurrent biologic therapy
Chemotherapy:
* No prior cytotoxic therapy
* No concurrent cytotoxic therapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior major surgery
Other:
* No other concurrent anticancer therapy
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Beverly Drucker, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-01032
Identifier Type: -
Identifier Source: secondary_id
NCI-3031
Identifier Type: -
Identifier Source: secondary_id
CDR0000068678
Identifier Type: -
Identifier Source: org_study_id