r115777 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. purpose: phase i trial to study the effectiveness of r115777 in treating patients who have advanced solid tumors.

objectives: * determine the maximum tolerated dose of r115777 in patients with advanced malignant solid tumors. * assess the toxicity of this drug in these patients. * determine, preliminarily, the efficacy of this drug in these patients. * determine the potential predictors of response in patients treated with drug. outline: this is a multicenter, dose-escalation study. patients receive oral r115777 twice daily on weeks 1 and 3. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of r115777 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a minimum of 20 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant tumors deemed to be incurable or refractory to therapy * advanced, recurrent, or metastatic disease * previously treated with at least 1 chemotherapy regimen * brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * wbc at least 3,500/mm3 * absolute granulocyte count at least 1,500/mm3 * platelet count at least 75,000/mm3 hepatic: * bilirubin no greater than 2.5 times upper limit of normal (uln) * sgot no greater than 2.5 times uln renal: * creatinine clearance at least 60 ml/min or * creatinine no greater than 1.6 mg/dl other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study prior concurrent therapy: biologic therapy: * no concurrent biologic therapy chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) endocrine therapy: * see disease characteristics * no concurrent hormonal therapy radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy and recovered * no prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present * no concurrent radiotherapy to measurable lesions surgery: * see disease characteristics * at least 3 weeks since prior major surgery and recovered other: * at least 2 weeks since prior proton pump inhibitors (e.g., omeprazole) * concurrent h2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between h2 blocker/antacid intake and r115777 dosing

Keywords: unspecified adult solid tumor, protocol specific