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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00551733
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable; sputum cytology alone is not acceptable for determining cell type
* Must meet one of the following criteria:
* Recurrent disease following completion of radiation or surgery
* Stage IIIB disease and not a candidate for combined modality therapy (primary radiation therapy or surgery)
* Stage IV disease
* Patients may have either measurable or nonmeasurable disease according to RECIST criteria
* Baseline estradiol \> 30 pg/mL
* Patients on hormone replacement therapy are eligible provided baseline estradiol \> 30 pg/mL
* Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site's institutional standards
* Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen
* Patients must have recovered from therapy for their brain metastases with no evidence of significant unstable neurological symptoms within the 4 weeks before study randomization
* No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology
PATIENT CHARACTERISTICS:
* Female
* ECOG performance score 0-2
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or other hereditary bilirubin defects may be included regardless of bilirubin levels)
* SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN \[CTC grade 0 to 2\] if due to liver metastases)
* Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with laboratory documentation that demonstrates bone origin
* No pregnant women or nursing mothers
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No known hypersensitivity to study drugs or excipients
* Meets all of the following criteria:
* No weight loss \> 10% in previous 6 months
* Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight loss
* LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months
* BMI ≤ 35
* No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer
* No neuropathy grade 2 or greater
* No clinically significant active infection for which active therapy is underway
* No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months
* Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable
* No circumstance that would preclude completion of the study or the required follow-up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from major surgery
* At least 7 days since prior local palliative radiotherapy
* At least 30 days since prior radiation therapy with curative intent
* At least 4 weeks since prior investigational therapy, unless local requirements are more stringent
* No prior systemic chemotherapy for the treatment of lung cancer, including systemic radiosensitizers used to treat brain metastases or any biologic agents
* No concurrent non-protocol-specified systemic antitumor therapy
* No concurrent amifostine, investigational agents, other cytotoxic agents for this disease
* No concurrent radiotherapy (with the exception of radiotherapy for brain or bone metastases for palliative purposes or radiotherapy for a condition other than NSCLC that was ongoing at the time of randomization)
* Patients receiving palliative radiotherapy (treatment for symptomatic metastatic disease) may be treated while on study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00551733
Study Brief:
Protocol Section:
NCT00551733