Clinical trial NCT00093756 (phase 1/phase 2, status: completed)
Conditions: recurrent non-small cell lung cancer, stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bortezomib, paclitaxel, carboplatin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        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