Clinical trial NCT00312728 (phase 2, status: completed)
Conditions: non-small cell lung cancer, brain neoplasms
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6
Drugs: bevacizumab, first-line chemotherapy agents, second-line chemotherapy agents
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma

          -  Treated brain metastases without evidence of progression or hemorrhage after
             treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during
             the screening period

          -  Appropriateness for first- or second-line systemic therapy for advanced NSCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Age ≥ 18 years

          -  For women of childbearing potential and sexually active males, use of an accepted and
             effective method of contraception (e.g., hormonal or barrier methods, abstinence)
             prior to study entry and for the duration of the study

        Exclusion Criteria:

          -  Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1

          -  Progressive neurologic symptoms

          -  Active malignancy other than lung cancer

          -  Current, recent, or planned participation in an experimental drug study

          -  Prior treatment with an investigational or marketed agent that acts by
             anti-angiogenesis mechanisms

          -  Gross hemoptysis within 3 months prior to Day 1

          -  Inadequately controlled hypertension

          -  Unstable angina or New York Heart Association Grade II or greater congestive heart
             failure (CHF)

          -  Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
             months prior to Day 1

          -  Myocardial infarction within 6 months prior to Day 1

          -  Stroke within 6 months prior to Day 1

          -  Active symptomatic peripheral vascular disease within 6 months prior to Day 1

          -  History of significant vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Known hypersensitivity to any components of bevacizumab

          -  Inadequate organ function

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

          -  Urine protein/creatinine (UPC) ratio of ≥ 1.0

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1, or anticipation of need for major surgical procedure during the course
             of the study

          -  Pregnancy or lactation

          -  Known evidence of disseminated intravascular coagulation (DIC)

          -  Active infection or fever > 38.5°C within 3 days prior to Day 1

          -  Any other medical condition (including mental illness or substance abuse) deemed by
             the clinician to be likely to interfere with a patient's ability to sign informed
             consent, cooperate and participate in the study, or interfere with the interpretation
             of the results