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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00045604
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed small cell lung cancer
* Extensive stage disease
* Measurable or evaluable indicator lesion
* No symptomatic or uncontrolled brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 4,000/mm3
* Platelet count at least 160,000/mm3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than 1 mg/dL
* AST no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN
Renal
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No uncontrolled cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study
* No other active cancer except previously treated carcinoma in situ, non -melanoma skin cancer, or stage I prostate cancer
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study
* No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis)
Endocrine therapy
* Not specified
Radiotherapy
* At least 2 weeks since prior radiotherapy to major bone marrow-containing areas
Surgery
* Not specified
Other
* No concurrent warfarin for therapeutic anticoagulation
* Low-molecular weight heparin or heparin allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00045604
Study Brief:
Protocol Section:
NCT00045604