Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy

NCT ID: NCT00801385

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

• 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.

Secondary

• 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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

erlotinib hydrochloride

Intervention Type: DRUG

sorafenib tosylate

Intervention Type: DRUG

DNA analysis

Intervention Type: GENETIC

mutation analysis

Intervention Type: GENETIC

polymerase chain reaction

Intervention Type: GENETIC

protein analysis

Intervention Type: GENETIC

protein expression analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• WBC 4,000-12,000/μL
• Neutrophil ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.0 times ULN
• Alkaline phosphatase ≤ 2.0 times ULN
• Serum creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• No active clinically serious infections
• No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
• Able to swallow oral medications
• No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy
• No prior anti-EGFR targeted therapy
• At least 4 weeks since prior surgery
• At least 4 weeks since prior and no concurrent radiotherapy

• No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
• No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Principal Investigators

Joo-Hang Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Joo-Hang Kim, MD

Role: primary

kjhang@yuhs.ac

82-2-2228-8131

References

Lim SM, Cho BC, Kim SW, Kang SY, Heo DS, Kim HT, Lee DH, Kim DW, Jung M, Choi JH, Shim HS, Choi JR, Kim JH. A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Lung Cancer. 2016 Mar;93:1-8. doi: 10.1016/j.lungcan.2015.12.005. Epub 2015 Dec 29.

Reference Type: DERIVED

PMID: 26898607 (View on PubMed)

Other Identifiers

YONSEI-4-2008-0160

Identifier Type: -

Identifier Source: secondary_id

CDR0000618003

Identifier Type: -

Identifier Source: org_study_id