Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive NSCLC: A Randomized Single-Blind Placebo-Controlled Phase II Study

Inclusion Criteria:

- Histologically or cytologically proven NSCLC, including squamous cell carcinoma.

- Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent
disease.

- Known CNS metastases if patients are asymptomatic and have completed whole brain or
stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to
starting treatment on this protocol. Must be off dexamethasone at the time of
starting treatment.

- Must have completed radiotherapy at least two weeks prior to registration. Prior
radiation therapy is eligible if patient has a measurable lesion that has not been
irradiated.

- Must have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension (RECIST criteria).

- Lesions that are not considered measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- ECOG performance status of 0-1.

- Life expectancy ≥ 3 months.

- Adequate bone marrow function, absolute neutrophil count ≥1,500/mm3, hemoglobin ≥9.9
gm/dl, and platelet count ≥100,000/mm3.

- Adequate liver function defined as bilirubin ≤ 1x upper level of the institutional
normal (ULIN). AST and ALT and Alkaline Phosphatase must be within the range allowing
for eligibility. In determining eligibility the more abnormal of the two values (AST
or ALT) should be used. See protocol.

- Must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or
calculated creatinine clearance ≥ 60 ml/min for patients with creatinine levels above
2.0 mg/dl.

- Must have recovered from uncontrolled intercurrent illness, including ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris or
cardiac arrhythmia.

- Use of adequate contraception (hormonal or barrier method of birth control) for the
duration of study participation and continued for at least three months after
completing treatment. Non-pregnant status will be determined in all women of
childbearing potential.

- Age > 18.

- Patients must have given written informed consent.

- Entry to this study is open to both men and women and to all racial and ethnic
subgroups. The goal is to accrue a minimum of 44 patients of African-American
ancestry and a maximum of 120 non-African-American patients. Classification of
patient race and ancestry will be based on patient's self-identification on the
consent form for the clinical trial.

Exclusion Criteria:

- History of severe hypersensitivity reaction to Docetaxel or other drugs formulated
with polysorbate 80.

- Grade 3 or 4 neuropathy.

- Women who are pregnant or breast-feeding.

- Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including
neoadjuvant or adjuvant chemotherapy.

- Currently active second malignancy other than non-melanoma skin cancer. Currently
active malignancy does not include prior malignancy treated with therapy and
considered to have less than 30% risk of relapse.