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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00064012
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Locally advanced (stage IIIB) or metastatic (stage IV) disease
* Inoperable disease
* Relapsed or refractory disease
* Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease
* Measurable or evaluable disease
* No symptomatic or inadequately treated brain metastases
* No CNS disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.0 g/dL
* Absolute neutrophil count greater than 1,500/mm\^3
Hepatic
* AST and ALT less than 3 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN
* Hepatitis B surface antigen negative
* Hepatitis C negative
Renal
* Creatinine less than 1.8 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* No poorly controlled hypertension
Immunologic
* No active systemic infection requiring treatment
* No prior allergic reaction attributable to compounds containing boron or mannitol
* HIV negative
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No peripheral neuropathy grade 2 or greater
* No diabetes mellitus
* No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 6 weeks since prior monoclonal antibody therapy
* No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No prior docetaxel
* Prior paclitaxel allowed
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery
* No concurrent surgery for cancer management or treatment
Other
* More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix
* More than 4 weeks since prior investigational agents
* No prior bortezomib
* No other concurrent investigational agents
* No other concurrent clinical research study participation
* No other concurrent antineoplastic therapy
* No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00064012
Study Brief:
Protocol Section:
NCT00064012