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PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00023855   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: April 4, 2009   History of Changes

September 13, 2001
April 4, 2009
June 2001
 
 
 
Complete list of historical versions of study NCT00023855 on ClinicalTrials.gov Archive Site
 
 
 
PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors

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.

OBJECTIVES:

  • 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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: bortezomib
  • Drug: doxorubicin hydrochloride
 
LoConte NK, Thomas JP, Alberti D, Heideman J, Binger K, Marnocha R, Utecht K, Geiger P, Eickhoff J, Wilding G, Kolesar J. A phase I pharmacodynamic trial of bortezomib in combination with doxorubicin in patients with advanced cancer. Cancer Chemother Pharmacol. 2008 Dec;63(1):109-15. Epub 2008 Mar 6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin normal

Renal:

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

Cardiovascular:

  • MUGA at least 45%

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent investigational or commercial agents for treatment of this malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023855
 
CDR0000068870, WCCC-CO-01901, NCI-3771
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: James P. Thomas, MD, PhD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP