Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer

It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:

• oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
• docetaxel 30mg/m2 on Days 1 and 8

Cycles are to be repeated every 28 days for a maximum of 6 cycles.

Inclusion Criteria:

• Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
• Patients must have measurable disease
• Age greater than or equal to 18 years
• ECOG performance score of 0, 1, or 2
• Absolute neutrophil count (ANC) > 1,500
• Platelets > 100,000
• Serum creatinine < 1.5mg/dL
• Serum total bilirubin < 1.5mg/dL
• Alkaline phosphatase < 3 times the upper limit of normal
• SGOT/SGPT < 3 times the upper limit of normal
• Patients must be recovered from the effects of any prior surgery or RT.
• Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
• Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.

Exclusion Criteria:

• Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
• Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
• History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
• Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
• Patients who have had prior chemotherapy for lung cancer
• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
• Grade 2 peripheral neuropathy
• Patients who are pregnant or lactating
• Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
• History of allogeneic transplant
• Known HIV, hepatitis B or C (active, previously treated, or both)