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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00074204
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIB with pleural effusion OR stage IV disease
* Recurrent disease after primary treatment with radiotherapy or surgery allowed
* Measurable disease or nonmeasurable disease
* Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Cystic lesions
* Abdominal masses not confirmed and followed by imaging techniques
* No symptomatic CNS metastases
* Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease)
* Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease)
Renal
* Creatinine no greater than 1.5 mg/dL
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active and ongoing infection
* No concurrent serious systemic disorder that would preclude study participation
* No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission
* Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids)
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* At least 3 weeks since prior therapy for cancer
* More than 4 weeks since prior investigational agents
* No other concurrent experimental medications
* No other concurrent therapy for cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00074204
Study Brief:
Protocol Section:
NCT00074204