Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Oxaliplatin + Docetaxel
Intervention description: Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
Intervention MeSH terms: Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non small Cell Lung Cancer Stage IIIb and IV

Summary:

      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.
    

Eligibility criteria:

        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)