Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
|ClinicalTrials.gov Identifier: NCT00801385|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : December 3, 2008
Last Update Posted : August 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: erlotinib hydrochloride Drug: sorafenib tosylate Genetic: DNA analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: protein analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis||Phase 2|
- To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens.
- To assess the response duration in patients treated with this regimen.
- To assess the disease control rate in patients treated with this regimen.
- To assess the progression-free survival of patients treated with this regimen.
- To assess the overall survival of patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
- To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||June 2009|
- Tumor response based on RECIST criteria
- Response duration in patients with confirmed objective response
- Disease control rate
- Overall survival
- Progression-free survival
- Biomarker analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801385
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Joo-Hang Kim, MD 82-2-2228-8131 firstname.lastname@example.org|
|Principal Investigator:||Joo-Hang Kim, MD||Yonsei University|