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

The Ohio State University

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: sorafenib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00754923

OSU-08017

NCI-2011-03192 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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