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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023855
• Other study ID #: CDR0000068870
• Secondary ID: P30CA014520WCCC-
• Status: Completed
• Phase: Phase 1
• Start date: June 2001

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• bortezomib

• doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Phar — View Citation