Clinical trial NCT00073385 (phase 2, status: completed)
Conditions: carcinoma, non-small-cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: pivanex, docetaxel
SMILES: CCCC(=O)OCOC(=O)C(C)(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
             Treatment with one prior platinum-based chemotherapy regimen (Eligible patients may
             include:

               1. Patients previously treated with adjuvant or neoadjuvant chemotherapy (must be
                  completed within 6 months prior to randomization) or

               2. Patients who have received chemotherapy for advanced or metastatic lung cancer);

          -  Recurrent or progressive NSCLC (local, distant, or both) following initial
             chemotherapy);

          -  Measurable or non-measurable disease;

          -  Males and females, age => 18 years;

          -  Adequate renal function with creatinine => 1.5 mg/dl;

          -  Adequate liver function with alkaline phosphatase => 2.5 X upper limit of normal,
             SGOT, and SGPT => 1.5 X upper limit of normal; and total bilirubin => upper limit of
             normal;

          -  Adequate bone marrow function: platelets > 100,000/mm3, hemoglobin => 9 g/dL, and
             absolute neutrophil count (ANC) => 1,500 cells/mm3;

          -  Able to give informed consent;

          -  Discontinuation of previous surgery, radiation therapy or cancer chemotherapy at least
             four weeks prior to randomization (six weeks if a prior nitrosourea or mitomycin C),
             with recovery from treatment-associated toxicity;

          -  A predicted life expectancy of at least 12 weeks; and

          -  ECOG performance status of 0, 1, or 2.

        Exclusion Criteria:

          -  Receipt of more than one chemotherapy regimen for NSCLC;

          -  A second malignancy within the last 5 years other than curatively treated
             carcinoma-in-situ or non-melanoma skin cancer;

          -  Pregnant or lactating females (Females of childbearing potential must have a negative
             pregnancy test and all male and female patients of reproductive potential must agree
             to use adequate birth control);

          -  Known HIV-positive patients;

          -  Acute medical problems, such as ischemic heart or lung disease or uncontrolled
             systemic infection;

          -  Patients with any underlying medical conditions or circumstance, which would
             contraindicate therapy with study treatment, affect compliance or impair evaluation of
             study endpoints;

          -  Patients receiving investigational agents within 30 days of the screening visit;

          -  Known allergy to reagents in the study;

          -  Prior docetaxel therapy;

          -  Symptomatic or untreated brain metastases (Patients with brain metastases are eligible
             if they are clinically and neurologically stable for > 4 weeks since therapy
             (radiation therapy, radiosurgery/gamma knife; surgical resection) as determined by the
             investigator and either off corticosteroids or on a stable dose of corticosteroids).