Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cisplatin; Docetaxel; Pemetrexed disodium; Radiation therapy
Intervention description: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Intervention MeSH terms: Docetaxel; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 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 cisplatin, pemetrexed disodium, and docetaxel,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Giving more than one chemotherapy drug (combination chemotherapy) together with radiation
      therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium
      together with radiation therapy followed by docetaxel works in treating patients with stage
      III non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of
             the following staging criteria:

               -  Stage IIIA disease, meeting all of the following criteria:

                    -  Mediastinal lymph node involvement

                         -  Greater than one mediastinal lymph node enlarged on CT scan, confirmed
                            by positron emission tomography (PET) scan

                    -  Paralyzed left vocal cord with separate lung primary distinct from the
                       aorto-pulmonary lymph nodes on the CT scan

               -  Stage IIIB disease, meeting all of the following criteria:

                    -  N3 lymph node involvement

                         -  Enlarged N3 lymph nodes on CT scan confirmed by PET scan

                              -  Lymph node involvement may not extend to cervical lymph nodes
                                 other than supraclavicular lymph nodes

                    -  Right-sided primary tumor with left vocal cord paralysis

                    -  Evidence of tumor extension into the mediastinum and/or mediastinal
                       structures by mediastinoscopy, bronchoscopy, or CT scan

                    -  No evidence of malignant pleural effusion unless effusion is only evident on
                       CT scan

                    -  No more than 1 parenchymal lesions on the same or opposite sides of the lung

          -  No brain metastases by CT scan or MRI

        PATIENT CHARACTERISTICS:

          -  SWOG performance status 0 or 1

          -  Platelet count ≥ 100,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Creatinine clearance ≥ 45 mL/min

          -  Bilirubin normal

          -  Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving
             greater than 20 Gy of radiation ≤ 40%

          -  FEV_1 ≥ 70% of predicted

          -  DLCO ≥ 50 mL/min

          -  No other concurrent malignancy

               -  Prior malignancy allowed provided it is in clinical control and is not likely to
                  impact clinical outcome in the opinion of the treating physician

          -  No peripheral neuropathy ≥ grade 2

          -  No serious medical illness, including, but not limited to, any of the following:

               -  Uncontrolled congestive heart failure

               -  Uncontrolled angina

               -  Myocardial infarction

               -  Cerebrovascular event within the past 6 months

               -  History of chronic active hepatitis

               -  History of HIV infection

               -  Active bacterial infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or
             dexamethasone

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for NSCLC

          -  No concurrent participation in another therapeutic investigational study

          -  Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium
             administration provided the patient has normal renal function

          -  No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days
             before, during, and for 2 days after pemetrexed disodium administration

               -  Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or
                  celecoxib) must be willing or able to discontinue usage 5 days prior to, during,
                  and for 2 days after pemetrexed disodium administration