Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer

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).