MS 209 Plus Docetaxel in Treating Patients With Advanced 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors. * Assess the toxicity of this regimen in these patients. OUTLINE: This is a dose escalation, multicenter study of MS-209. Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course. On day 1 of the 2nd course, patients receive MS-209 orally followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 4-7 courses (including course with docetaxel alone). Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose limiting toxicities. Patients are followed every 6 weeks. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

docetaxelDRUG

dofequidar fumarateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignant solid tumor * No gastric cancer * No brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 11.2 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.4 mg/dL Cardiovascular: * Normal cardiac function * Left ventricular ejection fraction normal Other: * No digestive disease that hampers absorption * No unstable systemic disease or uncontrolled infection that precludes study * No psychological, familial, sociological, or geographical condition that precludes compliance * Not pregnant or nursing * Fertile patients must use effective contraception 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 prior docetaxel * No other concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy (6 weeks if extensive) Surgery: * Not specified Other: * No other concurrent anticancer drugs * No other concurrent investigational therapies * No H2-blockers, proton pump inhibitors, sucralfate or any other drug that would impair absorption * No concurrent drugs exhibiting liver, kidney, heart or lung toxicity * No concurrent MDR-modulating drugs (e.g., calcium antagonists, immunosuppressives) * No concurrent antifungals (ketoconazole, fluconazole) or antibiotics (clarithromycin, erthromycin) that interfere with MS-209 metabolism

Locations (3)

Centre Oscar Lambret

Lille, France

Institut Curie - Section Medicale

Paris, France

Haemato-Onkologische Praxis und Tagesklinik

Munich (Muenchen), Germany

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.