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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT00397293
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
* Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
* All patients must have measurable disease.
* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
* ECOG performance status 0-1
* Adequate hematologic function
* Adequate liver and renal function
* Ability to swallow oral medication
Exclusion Criteria:
* Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
* Prior chemotherapy regimen containing irinotecan.
* Active secondary malignancy.
* Unstable or progressive brain metastases.
* Prior history of radiation therapy to \> 25% of the bone marrow.
* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00397293
Study Brief:
Protocol Section:
NCT00397293