Sorafenib Treatment in Non-Small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

NCT00922584 | Completed Phase 2 DMC

• 1 other identifier: C-TONG0805
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This trial's aim is to evaluate the efficacy and toxicity of sorafenib in relapsed advanced Non-Small Cell Lung Cancer (NSCLC) after failure of epidermal growth factor receptors-tyrosine kinase inhibitor (EGFR-TKI) treatment and to explore the correlation between clinical outcomes and biochemical modulation of signal transduction pathways.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; Sorafenib; targeted therapy

Outcome Measures

Primary Outcomes (1)

• Disease control rate (CR+PR+SD)

  1 year

Secondary Outcomes (5)

• Response duration

  2 years

• time-to-progression

  2 years

• progression free survival

  2 years

• overall survival

  2 years

• safety profile

  2 years

Study Arms (1)

sorafenib

EXPERIMENTAL

Patients with stage IIIB/IV NSCLC who failed EGFR-TKI therapy will receive oral sorafenib 400 mg twice daily until disease progression or unacceptable toxicity.

Drug: sorafenib (Nexavar)

Interventions

sorafenib (Nexavar) DRUG

oral sorafenib 400 mg, twice daily, until disease progression or unacceptable toxicity

sorafenib

Eligibility Criteria

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

You may qualify if:

• Histological or cytological documented stage IIIB (not amenable for radical regional therapy) or stage IV NSCLC. The pathological diagnosis must be adenocarcinoma with or without bronchioalveolar carcinoma. Sputum cytology alone is excluded.
• Recurrent or progressive disease after prior one EGFR-TKI treatment. The patient must have stopped the EGFR-TKI treatment for at least two weeks. The response to EGFR-TKI should be partial response or complete response or stable disease (the duration of stable disease should be more than 3 months). Patients who had never received chemotherapy or received one regimen chemotherapy before EGFR-TKI are eligible.
• Prior surgery, including palliative surgery, is permitted if performed 4 weeks before the start of study treatment and the patient is fully recovered.
• Prior localized radiotherapy 4 weeks before the start of study is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented. Patient has recovered from CTCAE grade 3/4 toxicity of radiotherapy. Palliative radiotherapy within 4 weeks of start of study is also permitted.
• Age \> 18 years.
• ECOG Performance Status of 0, 1,or 2. Life expectancy of at least 3 months. Measurable disease, according to the RECIST, the presence of at least one uni-dimensional measurable lesion with longest diameter \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hemoglobin \> 9.0 g/dl
• Platelet count \> 75x109/L
• Total bilirubin ≤ 1.5 x upper limit of normal
• ALT and AST \< 2.5 x upper limit of normal without liver metastasis, ALT and AST \< 5 x upper limit of normal with liver metastasis.
• International normalized ratio (INR) ≤ 1.5 x the upper limit of normal and prothrombin time (PT) ≤ 1.5 x the upper limit of normal. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
• Serum creatinine \< 1.5 x upper limit of normal.

You may not qualify if:

• Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial.
• Mixed small cell and non-small cell lung cancer histology. Other pathological types of NSCLC than adenocarcinoma and bronchioloalveolar cell carcinoma.
• Failure of EGFR-TKI is due to toxicity.
• Prior with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
• Prior exposure to sorafenib or other agents targeting the Ras/MARK pathway or VEGFR.
• Any unresolved toxicity more than CTCAE grade 2 from previous anti-cancer therapy.
• Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0(Conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTC \> 0.45-0.47 second); however, patients with grade 2 atrial fibrillation may be included.
• Significant cardiovascular event: congestive heart failure \> NYHA class 2; unstable angina, active CAD (myocardial infarction more than 6 months prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
• Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication (sorafenib) or that might affect the interpretation of the results or render the subject at high risk from treatment.
• Central nervous system (CNS) tumor or metastatic tumor.
• Clinically significant gastrointestinal bleeding within 30 days of study entry.

Sponsors & Collaborators

• Chinese Society of Lung Cancer: lead

Study Sites (1)

WuYiLong

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Zhou Q, Zhou CC, Chen GY, Cheng Y, Huang C, Zhang L, Xu CR, Li AW, Yan HH, Su J, Zhang XC, Yang JJ, Wu YL. A multicenter phase II study of sorafenib monotherapy in clinically selected patients with advanced lung adenocarcinoma after failure of EGFR-TKI therapy (Chinese Thoracic Oncology Group, CTONG 0805). Lung Cancer. 2014 Mar;83(3):369-73. doi: 10.1016/j.lungcan.2013.12.014. Epub 2014 Jan 5.

  PMID: 24440279 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wu Yi Long, Professor

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Chinese Society of Lung Cancer/Chief of Lung Cancer Research Institute & Cancer Center/Vice President of Guangdong General hospital

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 17, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

CN (1)