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 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT00083161
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer
* Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)
* Measurable disease
* Concurrent CNS metastases allowed provided patient remains asymptomatic
* Radiotherapy or surgery for uncontrolled symptoms allowed before study entry
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
* ALT ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Concurrent corticosteroids for brain metastases allowed
Radiotherapy
* See Disease Characteristics
* Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00083161
Study Brief:
Protocol Section:
NCT00083161