Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
Condition: Lung Cancer; Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Carboplatin; Radiation therapy; Surgical resection
Intervention description: 20 mg/m2, 75 mg/m2 infusion; AUC of 2 and 6 infusion; NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.; All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess how well this particular combination of chemotherapy,
      radiation and surgery works to help people with locally advanced lung cancer, how well PET
      scans indicates whether someone has responded to chemotherapy and radiation, and gene
      expression patterns related to outcomes in patients with locally advanced lung cancer who
      receive this treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

        Histologically confirmed stage IIIA or IIIB NSCLC

          -  Patients must have measurable disease

          -  No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.

          -  Age>18 years

          -  Life expectancy >12 months

          -  ECOG performance status 0-1

          -  Normal organ and marrow function

          -  Medically fit for surgery at time of enrollment.

          -  Women of childbearing potential and men must agree to use adequate contraception prior
             to study entry and for the duration of the study. Women must have a negative pregnancy
             test prior to enrollment.

          -  Ability to understand and willingness to sign the consent form.

        Exclusion Criteria:

          -  Previous chemotherapy, radiation therapy or any other systemic treatment for their
             NSCLC.

          -  Patients receiving any other investigational agents.

          -  Known metastatic disease (brain or any other site)

          -  History of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80 or with allergic reactions to compounds of similar chemical
             composition to carboplatin or other agents used in the study.

          -  Peripheral neuropathy >grade 1

          -  Uncontrolled concurrent illness

          -  Pregnant women

          -  Weight loss>10% in the past 3 months before diagnosis.

          -  Hyperglycemia - exclusion from PET analysis

          -  HIV positive patients receiving combination anti-retroviral therapy because of
             possible pharmacokinetic interactions with docetaxel and carboplatin or other agents
             administered during the study.