{"groups":[{"description":"Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.\n\nCisplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"FG000","title":"Arm I (Paclitaxel, Cisplatin)"},{"description":"Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.\n\nCisplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nVinorelbine Tartrate: Given IV","id":"FG001","title":"Arm II (Vinorelbine, Cisplatin)"},{"description":"Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.\n\nCisplatin: Given IV\n\nGemcitabine Hydrochloride\n\nQuality-of-Life Assessment: Ancillary studies","id":"FG002","title":"Arm III (Gemcitabine, Cisplatin)"},{"description":"Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.\n\nCisplatin: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nTopotecan Hydrochloride: Given IV","id":"FG003","title":"Arm IV (Topotecan, Cisplatin)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Improper prior treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}],"type":"Poor risk"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}],"type":"Pathology"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"No surgery"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"No tumor"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}],"type":"Other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"117"},{"groupId":"FG002","numSubjects":"119"},{"groupId":"FG003","numSubjects":"118"}],"type":"STARTED"},{"achievements":[{"comment":"Evaluable (treatment)","groupId":"FG000","numSubjects":"103"},{"comment":"Evaluable (treatment)","groupId":"FG001","numSubjects":"108"},{"comment":"Evaluable (treatment)","groupId":"FG002","numSubjects":"112"},{"comment":"Evaluable (treatment)","groupId":"FG003","numSubjects":"111"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"7"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.","recruitmentDetails":"From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004."}