{"groups":[{"description":"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.\n\nerlotinib: Given orally\n\ntemsirolimus: Given IV\n\npharmacological study: Correlative studies","id":"FG000","title":"Phase I (Erlotinib & Temsirolimus)"},{"description":"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.\n\nPHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.\n\ntherapeutic conventional surgery: Undergo surgical resection\n\nlaboratory biomarker analysis: Correlative studies","id":"FG001","title":"Phase II (Erlotinib & Temsirolimus)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"1 pt never had had RX due rapid decline"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"47"}],"type":"STARTED"},{"achievements":[{"comment":"12 of Phase I pts treated at MTD and hence considered part of the Phase II analysis","groupId":"FG000","numSubjects":"21"},{"comment":"12 additional pts from phase 1 study were used in analysis for Phase 2 as they were treated at MTD","groupId":"FG001","numSubjects":"47"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"Patients were enrolled between 2005 and 2008. Patients were recruited from outpatient medical clinics and referrals."}