Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT00953459
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed small cell lung cancer
* Chemotherapy naïve (extensive stage) OR sensitive relapse (\> 3 months since induction therapy) disease
* Measurable disease, as defined by RECIST criteria
* No brain metastases as assessed by CT scan or MRI performed \< 1 week before treatment
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy \> 12 weeks
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy)
* Total serum bilirubin ≤ 1.5 x ULN
* Serum albumin ≥ 3.0 g/dL
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study treatment
* No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within the past 6 months
* No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
* No hypertension (\> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents
* No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval \> 450 msec for males or \> 470 msec for females
* No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy, surgery, or investigational agents
* At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions
* No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors
* No concurrent treatment with steroids
* No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
* More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively
* Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis
* No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00953459
Study Brief:
Protocol Section:
NCT00953459