PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
NCT ID: NCT00023855
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2001-06-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bortezomib
doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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James P. Thomas, MD, PhD
Role: STUDY_CHAIR
Ohio State University Comprehensive Cancer Center
Locations
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University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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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. doi: 10.1007/s00280-008-0719-5. Epub 2008 Mar 6.
Other Identifiers
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WCCC-CO-01901
Identifier Type: -
Identifier Source: secondary_id
NCI-3771
Identifier Type: -
Identifier Source: secondary_id
CDR0000068870
Identifier Type: -
Identifier Source: org_study_id