Clinical trial NCT00077246 (phase 1/phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: paclitaxel albumin-stabilized nanoparticle formulation
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed stage IV non-small cell lung cancer

               -  Evidence of inoperable local recurrence or metastasis

                    -  Bone metastases or other nonmeasurable disease may not be only evidence of
                       metastasis

          -  Measurable disease documented radiographically

          -  No evidence of active brain metastases or leptomeningeal involvement

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1 OR

          -  Karnofsky 80-100%

        Life expectancy

          -  More than 12 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

        Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no
             radiologic evidence of hepatic metastases)

        Renal

          -  Creatinine ≤ 1.5 mg/dL

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception for 1 month before and
             during study participation

          -  No prior allergy or hypersensitivity to study drug

          -  No other concurrent active malignancy

          -  No pre-existing peripheral neuropathy grade 1 or greater

          -  No other concurrent clinically significant illness

          -  No concurrent serious medical risk factor involving any of the major organ systems
             that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for metastatic disease

          -  More than 4 weeks since prior cytotoxic chemotherapy

          -  No concurrent doxorubicin

          -  No other concurrent taxanes

          -  No concurrent anthracyclines

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 3 weeks since prior radiotherapy to a major bone marrow-containing area

          -  More than 4 weeks since prior radiotherapy except to a non-target lesion

               -  Prior radiotherapy to a target lesion allowed provided there has been clear
                  progression of the lesion since completion of radiotherapy

        Surgery

          -  Not specified

        Other

          -  Prior epidermal growth factor-targeted therapy allowed

          -  More than 4 weeks since prior investigational drugs

          -  No concurrent enrollment in another clinical trial in which investigational drugs are
             administered or investigational procedures are performed

          -  No concurrent treatment with any of the following:

               -  Ritonavir

               -  Saquinavir

               -  Indinavir

               -  Nelfinavir

          -  No concurrent anticonvulsants

          -  No other concurrent anticancer drugs

          -  No other concurrent investigational drugs