Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer Mixed tumors allowed unless small cell elements are present Stage IIIB or IV or recurrent disease At least 1 measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known brain metastases Performance status - ECOG 0-1 More than 3 months Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 2 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement present) Creatinine ≤ 2 mg/dL Creatinine clearance ≥ 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No peripheral neuropathy > grade 1 No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No more than 1 prior chemotherapy regimen Two prior chemotherapy regimens allowed provided 1 of the 2 regimens was gefitinib monotherapy as second-line therapy At least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or nitrosoureas) and recovered At least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom relief) and recovered Prior bortezomib allowed provided patient achieved at least a partial response (of at least 6 months duration), received no other therapy since the last dose of bortezomib, and has no residual toxicity greater than grade 1 No other concurrent investigational or commercial agents or therapies for malignancy
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.