Original Query: ALL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023855
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: bortezomib Drug: doxorubicin hydrochloride Phase 1

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.

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : June 2001
Primary Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023855

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: James P. Thomas, MD, PhD Ohio State University Comprehensive Cancer Center

Publications of Results:
Responsible Party: University of Wisconsin, Madison Identifier: NCT00023855     History of Changes
Other Study ID Numbers: CDR0000068870
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Liposomal doxorubicin
Proteasome Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors