A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)

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).