ms 209 plus docetaxel in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: 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.

Eligibility 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

Keywords: unspecified adult solid tumor, protocol specific