Clinical trial NCT00729612 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, paclitaxel albumin-stabilized nanoparticle formulation
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [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 advanced non-small cell lung cancer (NSCLC)
             meeting 1 of the following criteria:

               -  Stage IIIB disease with malignant pleural effusion

               -  Stage IV disease

               -  Recurrent disease

          -  Squamous cell histology allowed

          -  Not eligible for curative treatment or treatment with bevacizumab

          -  Measurable disease according to RECIST

          -  Tumor (paraffin blocks or slides) must be available for correlative biomarker studies

          -  No uncontrolled brain metastases (or leptomeningeal disease)

               -  Controlled brain metastases allowed

                    -  Able to receive appropriate therapeutic radiotherapy

                    -  Able to taper off all steroids without symptoms suggestive of increased
                       intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at
                       least 7 days

        PATIENT CHARACTERISTICS:

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0-2

          -  ANC (absolute neutrophil count) ≥ 1.5 x 10^9/L

          -  Platelets ≥ 100 x 10^9/L

          -  Hemoglobin ≥ 9.0 g/L

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 2.5 times upper
             limit of normal

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mg/mL

          -  No known HIV or hepatitis B or C

          -  Not pregnant

          -  Negative pregnancy test

          -  Thrombotic or embolic event within the past 6 months allowed, provided adequately
             controlled with therapeutic anticoagulation

          -  Hemoptysis allowed, provided it is not life threatening or requires palliative
             procedures (e.g., endobronchial therapy or radiotherapy)

          -  No cardiac disease, including any of the following:

               -  NYHA (New York Heart Association) class III-IV congestive heart failure

               -  Unstable angina (angina symptoms at rest)

               -  New onset angina (began within the past 3 months)

               -  Myocardial infarction within the past 6 months

          -  No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or
             diastolic BP > 90 mm Hg despite optimal medical management

          -  No peripheral neuropathy ≥ grade 2

          -  No active clinically serious infection > CTCAE grade 2

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No significant traumatic injury within the past 4 weeks

          -  No evidence or history of bleeding diathesis or coagulopathy

          -  No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma
             in situ of the cervix, or other cancer for which the patient has been disease-free for
             2 years

               -  Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of
                  NSCLC allowed, however metastatic prostate cancer currently receiving hormonal
                  therapy or chemotherapy is not allowed

          -  No significant psychiatric illness, in the opinion of the principal investigator, that
             would prevent adequate informed consent or render therapy unsafe

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Concurrent therapeutic anticoagulation, > 325 mg acetylsalicylic acid, or chronic
             non-steroid anti-inflammatory drug use allowed

          -  At least 14 days since prior and no concurrent radiotherapy

          -  More than 4 weeks since prior major surgery or open biopsy