Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer

Inclusion Criteria:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Locally advanced stage IIIA or IIIB disease that is considered unresectable
No stage IV disease
Requires radiotherapy
Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0-1
At least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
aspartate aminotransferase (AST) ≤ 3 times ULN
Creatinine ≤ 1.5 times ULN
No New York Heart Association class III or IV heart disease
Forced expiratory volume (FEV) FEV_1 ≥ 1 L OR 35% of predicted
Weight loss < 10% within the past 3 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No peripheral neuropathy ≥ grade 2
No other severe underlying disease that would preclude study participation
No uncontrolled infection
No unhealed wound within the past 2 weeks
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer
No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
No prior systemic chemotherapy for NSCLC*
No prior radiotherapy to the chest
More than 2 weeks since prior major surgery

Contraindications

Any of the following:

Pregnant wome
Nursing women
Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.

Any of the following prior therapies:

Prior radiation therapy to the chest
Prior systemic chemotherapy for NSCLC (phase II portion)
New York Heart Association classification III or IV (see Appendix II).
Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study.
uncontrolled infection.
Major surgery or unhealed wound ≤ 2 weeks prior to registration.
Prior history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer.
Peripheral neuropathy ≥grade 2