Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
docetaxel
+ dofequidar fumarate
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.30 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
Institut Curie - Section Medicale
Paris, FranceHaemato-Onkologische Praxis und Tagesklinik
Munich (Muenchen), Germany