PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: September 13, 2001
Last updated: August 15, 2013
Last verified: August 2013

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

PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: bortezomib
Drug: doxorubicin hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Study Start Date: June 2001
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in patients with advanced solid tumors.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of PS-341.

Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced solid tumor for which no curative treatment exists
  • Measurable or evaluable disease
  • No brain metastases or primary brain tumors



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • MUGA at least 45%


  • No serious active infection
  • No pre-existing neuropathy grade 2 or greater
  • No other concurrent illness that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy
  • No prior cumulative dose of doxorubicin exceeding 280 mg/m^2

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy


  • Not specified


  • No other concurrent investigational or commercial agents for treatment of this malignancy
  Contacts and Locations
Please refer to this study by its identifier: NCT00023855

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
Study Chair: James P. Thomas, MD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Publications: Identifier: NCT00023855     History of Changes
Other Study ID Numbers: CDR0000068870, P30CA014520, WCCC-CO-01901, NCI-3771
Study First Received: September 13, 2001
Last Updated: August 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014