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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT00072059
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Stage IIIB or IV
* Currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy)
* Antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents
* Hemoglobin no greater than 11 g/dL
* Transfusion independent
* No known primary or metastatic CNS malignancy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* More than 6 months
Hematopoietic
* See Disease Characteristics
* Platelet count 50,000-500,000/mm\^3
* No functional iron deficiency\* (e.g., transferrin saturation less than 20% OR serum ferritin less than 100 ng/mL)
* No known hemolysis NOTE: \*Concurrent iron supplementation to correct deficiency allowed
Hepatic
* Not specified
Renal
* Creatinine no greater than 2.5 mg/dL
Cardiovascular
* No clinically significant hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
* No acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding)
* No known cyanocobalamin deficiency
* No known folic acid deficiency
* No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L)
* No known resistance to epoetin administration
* No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 4 weeks since prior red blood cell transfusion
* More than 30 days since prior investigational drugs or regimens
* No prior enrollment and randomization to this study
* No other concurrent investigational drugs or regimens
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00072059
Study Brief:
Protocol Section:
NCT00072059