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

NCT00801385 | Unknown Phase 2

• 2 other identifiers: CDR0000618003YONSEI-4-2008-0160
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response based on RECIST criteria

Secondary Outcomes (5)

• Response duration in patients with confirmed objective response

• Disease control rate

• Overall survival

• Progression-free survival

• Biomarker analysis

Interventions

erlotinib hydrochloride DRUG

sorafenib tosylate DRUG

DNA analysis GENETIC

mutation analysis GENETIC

polymerase chain reaction GENETIC

protein analysis GENETIC

protein expression analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Advanced (stage IIIB-IV) or recurrent disease * Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen * At least 1 unidimensionally measurable lesion \> 10 mm by spiral CT scan or \> 20 mm by conventional CT scan * Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy * No known or suspected brain metastases * Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain * Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 26898607 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Sorafenib; Polymerase Chain Reaction; Immunohistochemistry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

KR (1)