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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00052494
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed extensive stage small cell lung cancer
* Incurable but amenable to treatment with chemotherapy
* c-kit positive by immunohistochemistry of original biopsy or other metastatic site
* At least one unidimensionally measurable lesion
* \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
* No prior radiotherapy to target measurable lesion(s), unless there is documented disease progression
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* ECOG 0-1 OR
* Karnofsky 70-100%
Life expectancy
* More than 6 weeks
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST and/or ALT ≤ 2.5 times upper limit of normal
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Gastrointestinal
* No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated
* No gastrointestinal disease that would impair drug absorption
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception prior to, during, and for 3 months after study participation
* No history of ototoxicity
* No history of peripheral neuropathy
* No traumatic injury within the past 21 days
* No ongoing or active infection
* No other concurrent significant medical condition that would preclude study participation
* No concurrent psychiatric condition or social situation that would preclude study compliance
* No other malignancy within the past 5 years except treated nonmelanoma skin cancer, carcinoma in situ, or stage A prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to more than 25% of marrow
Surgery
* More than 3 weeks since prior major surgery
* No prior surgical procedure impairing absorption
Other
* No prior c-kit-targeted therapy
* No concurrent therapeutic dose of warfarin
* Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent amifostine
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00052494
Study Brief:
Protocol Section:
NCT00052494