CHS 828 in Treating Patients With Solid Tumors

European Organisation for Research and Treatment of Cancer - EORTC

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 CHS 828 in treating patients who have solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine a safe dose of this regimen for phase II evaluation. * Determine the pharmacokinetic profile of this regimen in these patients. * Determine any antitumor activity in these patients. OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 4 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

CHS 828DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor not amenable to standard therapy * No symptomatic brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) Renal: * Creatinine no greater than 1.4 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active bacterial infection * No other nonmalignant disease * No alcoholism, drug addiction, or psychiatric disorders * Able to take oral medication PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy) * No concurrent radiotherapy (except palliative radiotherapy) Surgery: * Not specified Other: * No other concurrent investigational drugs * No other concurrent antitumor drugs

Locations (28)

Innsbruck Universitaetsklinik

Data from ClinicalTrials.gov

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