Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
docetaxel
+ dofequidar fumarate
Treatment Study
Summary
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Institut Curie - Section Medicale
Paris, FranceHaemato-Onkologische Praxis und Tagesklinik
Munich (Muenchen), Germany