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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00754923
• Other study ID #: OSU-08017
• Secondary ID: NCI-2011-03192
• Status: Terminated
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: April 2012

Study information

• Verified date: February 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival at 6 Months	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate	6 months
Secondary	Overall Survival Rate	Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC	Up to 2 years
Secondary	Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)	Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.	Up to 2 years
Secondary	Mutational Status for EGFR or Kras		up to 2 years

External Links

•   Jamesline