Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

Phase 1CompletedNCT00020748

Georgetown University

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.

OBJECTIVES: * Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and irinotecan in patients with advanced cancer. * Determine the objective antitumor responses in patients treated with this regimen. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days 1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of epirubicin is followed by sequential dose escalation of irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

epirubicin hydrochlorideDRUG

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically documented incurable malignancy for which there is no beneficial standard therapy * Locally unresectable or metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.2 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * Ejection fraction at least 50% by MUGA scan * No congestive heart failure Other: * Maintaining a reasonable state of nutrition * No frequent vomiting or severe anorexia * No weight loss greater than 10% of current body weight within the past 4 weeks * No other concurrent medical illness that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * Recovered from prior therapy

Locations (1)

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Data from ClinicalTrials.gov

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