Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

PRIMARY OBJECTIVES: I. To assess the safety and feasibility of ifetroban sodium (ifetroban) administration in patients with malignant solid tumors at high risk of metastatic recurrence, after completion of all planned (neo)adjuvant locoregional and systemic therapies. SECONDARY OBJECTIVES: I. To assess rate of metastatic recurrence after completion of ifetroban in patients with malignant solid tumors. EXPLORATORY OBJECTIVES: I. To quantify pharmacodynamic markers of ifetroban effects. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP 1 (IFETROBAN): Patients receive ifetroban sodium orally (PO) once daily (QD). Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. GROUP 2 (PLACEBO): Patients receive a placebo PO QD. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then up to 12 months.