Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB … (NCT00754923) | Clinical Trial Compass
TerminatedPhase 2
Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
United States11 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival at 6 Months
Timeframe: 6 months
Trial details
NCT IDNCT00754923
SponsorOhio State University Comprehensive Cancer Center