PS-341 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 6, 2001
Last updated: December 13, 2009
Last verified: December 2009

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

Condition Intervention Phase
Kidney Cancer
Drug: bortezomib
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of PS341 (NSC 681239) in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma

    • Metastatic disease
  • Unidimensionally measurable disease
  • No brain metastases



  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • ALT/AST no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent biologic therapy


  • No prior cytotoxic therapy
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • At least 4 weeks since prior major surgery


  • No other concurrent anticancer therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00017329

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Beverly Drucker, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00017329     History of Changes
Other Study ID Numbers: CDR0000068678, MSKCC-01032, NCI-3031
Study First Received: June 6, 2001
Last Updated: December 13, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on November 25, 2015