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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00387660
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:
* Previously untreated metastatic or extensive disease
* Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease
* Prior radiotherapy allowed
* Recurrent disease
* Limited, metastatic, or extensive disease
* Relapsed after prior chemotherapy, excluding irinotecan hydrochloride
* At least 90 days since prior chemotherapy
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques
* Known brain metastases allowed
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* White Blood Cells \> 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin ≤ 1.5 mg/dL
* SGOT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No medical disease that, in the opinion of the investigator, would preclude study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 10 days since prior radiotherapy (including brain)
* No prior irinotecan hydrochloride
* At least 2 weeks since prior and no concurrent anticonvulsants
* No concurrent radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00387660
Study Brief:
Protocol Section:
NCT00387660