Expired Study
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Madison, Wisconsin 53792


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00023855


Primary Contact:

Study Chair
James P. Thomas, MD, PhD
Ohio State University Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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