{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Time from start of treatment to first documented occurrence of progressive disease (PD). PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.","groups":[{"description":"docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week\n\nerlotinib hydrochloride: oral erlotinib hydrochloride once daily for up to 2 years in the absence of disease progression or unacceptable toxicity\n\nfluorescence in situ hybridization: Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA), immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.\n\npolymerase chain reaction: Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at baseline and periodically during study. Samples are analyzed for markers of angiogenic activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression profi","id":"OG000","title":"Oral Erlotinib Hydrochloride"}],"populationDescription":"Data not available because response data not collected","reportingStatus":"POSTED","timeFrame":"3 yrs after treatment","title":"Time to Progression (TTP)","type":"PRIMARY"}