{"groups":[{"description":"Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.","id":"FG000","title":"Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)"},{"description":"Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.","id":"FG001","title":"Arm B (Combination Chemotherapy and Placebo)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"59"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"42"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"123 participants registered-4 participants were inevaluable (2 refused not due to toxicity, 2 other).","recruitmentDetails":"Patients with histologically confirmed metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx or larynx who have an ECOG performance status of 0-2, measurable disease and no prior chemotherapy for their metastatic or recurrent disease were enrolled"}