{"eventGroups":[{"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":"EG000","otherNumAffected":21,"otherNumAtRisk":21,"seriousNumAffected":3,"seriousNumAtRisk":21,"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":"EG001","otherNumAffected":37,"otherNumAtRisk":59,"seriousNumAffected":2,"seriousNumAtRisk":59,"title":"Phase II (Erlotinib & Erlotinib)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Leukopenia","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"White blood Cells"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Thrombocytopenia","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"hypercholesterolemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":59,"numEvents":4}],"term":"hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"SGOT, SGPT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Liver Function Test abnormality"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":6},{"groupId":"EG001","numAffected":5,"numAtRisk":59,"numEvents":5}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Dry Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":21,"numEvents":8},{"groupId":"EG001","numAffected":10,"numAtRisk":59,"numEvents":10}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"lymphopenia","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":59,"numEvents":5}],"term":"Lymphocyte count decrease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Pain in Limb","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Pain in extremity"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Cardiac ischemia","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"normal ANC","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"retinopathy"}],"timeFrame":"Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study."}