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

University of Wisconsin, Madison

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

bortezomibDRUG

doxorubicin hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Data from ClinicalTrials.gov

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