Clinical trial NCT00735696 (phase 2, status: completed)
Conditions: non small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: paclitaxel, carboplatin
SMILES: [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 NSCLC

          -  Advanced NSCLC

          -  Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST
             1.0])

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1

          -  Age ≥ 18 years

          -  Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL,
             hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)

          -  Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline
             phosphatase ≤ 5 x the upper limit of normal (ULN)

          -  Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine
             clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or
             trace)

          -  Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5
             seconds above ULN

          -  Adequate contraception

          -  Signed informed consent

        Exclusion Criteria:

          -  Untreated CNS metastases

          -  Prior bevacizumab therapy

          -  Radiologically documented evidence of major blood vessel invasion or encasement by
             cancer

          -  Prior systemic chemotherapy for Stage IIIB/IV NSCLC

          -  Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior

          -  Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of
             the cervix

          -  Concurrent treatment with other anticancer therapy, including other chemotherapy,
             immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy

          -  Ongoing or active infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Uncontrolled thrombotic or hemorrhagic disorders

          -  Poorly-controlled hypertension

          -  Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of
             platelet function

          -  History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)

          -  Serious non-healing wound, ulcer, or bone fracture

          -  Undergone major surgery or subcutaneous venous access device placement. Post-operative
             bleeding complications or wound complications from a surgical procedures performed in
             the last 2 months

          -  Elective or a planned major surgery to be performed during the course of the trial

          -  Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria
             for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])

          -  If female, is pregnant or lactating

          -  Radiographic evidence of intratumor cavitation

          -  Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry