Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Induction Carboplatin; Induction Paclitaxel; Resection; Consolidation Carboplatin; Radiation Therapy; Consolidation Paclitaxel
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
      high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with
      radiation therapy before surgery may shrink the tumor so that it can be removed. Giving
      chemotherapy after surgery may kill any tumor cells remaining after surgery.

      PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together
      with radiation therapy works in treating patients who are undergoing surgery for stage III
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular
             involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast
             tumors are eligible if pathologic evidence of mediastinal nodal disease is present);

          2. Disease must be measurable;

          3. Mediastinal lymph nodes must be proven positive by pathologic review. All patients
             must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial
             needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by
             mediastinoscopy and found to be positive will be defined as N2 disease;

          4. Patients ≥ 18 years of age;

          5. Life expectancy ≥ 6 months;

          6. Zubrod performance status 0- 1 (See Appendix II);

          7. Pretreatment laboratory values must be as follows: White blood cell count (WBC) count:
             ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3;
             Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine:
             ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine
             aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL

          8. Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0
             then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on
             the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 =
             FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.

          9. Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation
             oncology; patient must be a potential surgical candidate prior to the initiation of
             therapy;

         10. Women of childbearing potential and male participants must practice an effective
             method of contraception during the study;

         11. Pretreatment evaluations required for eligibility include:

               -  A complete medical history & physical examination to include Zubrod performance
                  status, neurologic assessment, recent weight loss, usual weight, concurrent
                  non-malignant disease and therapy;

               -  Location, type, and size of measurable lesion must be recorded prior to
                  treatment;

               -  Complete blood count (CBC) with differential, platelet count, electrolytes, and
                  Mg++ within 14 days prior to study entry;

               -  Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium,
                  Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate
                  dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase
                  (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to
                  study entry;

               -  Women of childbearing potential must have a negative pre-study serum or urine
                  pregnancy test within 14 days prior to study entry.

               -  Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with
                  transbronchial needle aspirate to evaluate the extent of lymph node involvement;

               -  Computed tomography (CT) scan of the chest to include liver, and adrenal glands
                  within 6 weeks prior to study entry;

               -  Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any
                  suspicious areas outside of the local regional disease requires documented
                  evaluation of these findings to exclude metastatic disease;

               -  CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to
                  study entry;

               -  Electrocardiogram (EKG) and pulmonary function tests including forced vital
                  capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8
                  weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to
                  study entry.

         12. Patients must sign a study-specific informed consent prior to study entry.

        Exclusion Criteria:

          1. Small cell lung cancer; distant metastatic disease;

          2. Evidence of clinical or radiographic supraclavicular lymph node involvement;

          3. Bronchioalveolar carcinoma with lobar or multilobar involvement;

          4. Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod
             performance status 2 or greater;

          5. Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal
             cord dose to 48 Gy;

          6. Patients with malignant pleural effusion;

          7. Clinically evident superior vena cava syndrome;

          8. Prior systemic chemotherapy or radiation therapy to the thorax;

          9. Patients with known hypersensitivity to Cremophor EL;

         10. Patients receiving other investigational therapy;

         11. Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks
             to the participant and to the embryo or fetus;

         12. Patients with an active serious infection or other serious underlying medical
             condition that would impair their ability to complete protocol treatment;

         13. Dementia or significantly altered mental status that would prohibit the understanding
             and/or giving of informed consent.