PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

OBJECTIVES: Primary * Determine the maximum tolerated dose of PR-104 in combination with docetaxel or gemcitabine hydrochloride in patients with solid tumors. Secondary * Determine the safety of PR-104 in combination with docetaxel or gemcitabine hydrochloride in these patients. * Determine the antitumor activity of these regimens using disease-specific parameters, such as exams, scans, and tumor markers, in these patients. * Determine the pharmacokinetics of PR-104 and its alcohol metabolite in these patients. * Determine the pharmacokinetics of docetaxel and gemcitabine hydrochloride when administered with PR-104. * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia from these patients. * Examine metabolic changes in tumors using fludeoxyglucose F 18 positron emission tomography (PET) and PET imaging with fluoromisonidazole F 18 (a hypoxia-targeted radiopharmaceutical) in these patients. OUTLINE: This is a nonrandomized, open-label, uncontrolled, multicenter, dose-escalation study of PR-104. Patients are assigned to 1 of 2 treatment groups according to patient's malignancy and prior treatment history. * Group 1: Patients receive docetaxel IV over 60 minutes and PR-104 IV over 60 minutes on day 1. * Group 2: Patients receive gemcitabine hydrochloride IV over 30 minutes and PR-104 IV over 60 minutes on days 1 and 8. In both groups, treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients in each group receive escalating doses of PR-104 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Blood is collected at baseline and periodically during course 1 for pharmacokinetic analysis. Plasma samples are analyzed for biomarkers of tumor hypoxia at baseline and on days 2 and 8. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.