Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT ID: NCT00754923

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-04-30

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage IIIB or IV non-small cell lung cancer.

Secondary

• To determine the 1-year survival rate in patients treated with this drug.
• To assess the frequency and severity of adverse events associated with this drug in these patients.
• To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing.

After completion of study treatment, patients are followed every 3 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment: Sorafenib

Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.

Interventions

sorafenib

administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.

Intervention Type: DRUG

Other Intervention Names

Nexavar; sorafenib tosylate

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• Stage IIIB or IV disease
• Recurrent disease after prior surgery, chemotherapy, or radiotherapy
• No squamous cell histology or mixed tumor with > 50% squamous cells
• Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)
• No known brain metastasis

• Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

• ECOG(Eastern Cooperative Oncology Group)performance status 0-2
• ANC (Absolute Neutrophil Count)≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment
• No cardiac disease, including any of the following:

• New York Heart Association class III-IV congestive heart failure
• Unstable angina (anginal symptoms at rest)
• New-onset angina within the past 3 months
• Myocardial infarction within the past 6 months
• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
• No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
• No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks
• No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
• No active clinically serious infection > CTCAE grade 2
• No serious non-healing wound, ulcer, or bone fracture
• No evidence or history of bleeding diathesis or coagulopathy
• No known HIV infection or chronic hepatitis B or C
• No other malignancy except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer
• In situ cervical cancer
• Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence
• No condition that impairs the patient's ability to swallow whole pills
• No malabsorption problems
• No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
• No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than one prior systemic chemotherapy treatment for metastatic disease

• Prior treatment with EGFR inhibitors is not considered chemotherapy
• More than 4 weeks since prior major surgery or open biopsy
• No prior sorafenib tosylate
• No concurrent St. John's wort or rifampin
• Concurrent anticoagulation with warfarin or heparin allowed

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel A. Villalona, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2011-03192

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-08017

Identifier Type: -

Identifier Source: org_study_id