A Phase 2 interventional study of erlotinib hydrochloride and sorafenib tosylate in Lung Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.
Sponsored by Yonsei University · Phase 2, Interventional, and Treatment
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and downstream effectors of EGFR activation by IHC.
After completion of study therapy, patients are followed periodically.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 47 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan
No known or suspected brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior and no concurrent radiotherapy
Tumor response based on RECIST criteria
Response duration in patients with confirmed objective response
Disease control rate
Overall survival
Progression-free survival
Biomarker analysis
This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University