E7070 in Treating Patients With Solid Tumors

European Organisation for Research and Treatment of Cancer - EORTC30 enrolled

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 E7070 in treating patients who have solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients with solid tumors. * Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. * Propose a safe dose for phase II study. * Assess the pharmacokinetics of this drug at different dose levels in this patient population. * Determine any possible antitumor activity of this drug in this patient population. OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

indisulamDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy * No brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * Liver function tests no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 60 mL/min Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active bacterial infections (e.g., abscess or fistulae) * No other nonmalignant disease that precludes protocol therapy * No history of alcoholism, drug addiction, or psychotic disorders that preclude participation * No glaucoma PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No other concurrent antitumor drugs Endocrine therapy: * At least 4 weeks since prior anticancer hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) * No concurrent radiotherapy (except localized palliative radiotherapy) Surgery: * Not specified Other: * No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents * No other concurrent investigational drugs

Locations (26)

Innsbruck Universitaetsklinik

Innsbruck, Austria

Data from ClinicalTrials.gov

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