Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar
Intervention: cisplatin; pegfilgrastim; erlotinib hydrochloride; laboratory biomarker analysis; polymorphism analysis; pharmacogenomic studies; genetic linkage analysis; docetaxel
Intervention description: Given IV; Given SC; Given PO; Optional correlative study; Correlative study; Correlative study; Correlative study; Given IV
Intervention MeSH terms: Docetaxel; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well docetaxel given together with cisplatin and
      pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB
      or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and
      cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim,
      may increase the number of immune cells found in bone marrow or peripheral blood and may help
      the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride
      may kill more tumor cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic Documentation: Either histologic or cytologic documentation of non-small
             cell carcinoma (NSCLC) is necessary, and the following diagnostic categories are
             acceptable: squamous carcinoma, basaloid carcinoma, adenocarcinoma, bronchioloalveolar
             carcinoma, adenosquamous carcinoma, large cell carcinoma (not neuroendocrine),
             sarcomatoid carcinoma, and non-small cell carcinoma not otherwise specified (NOS);
             histologic or cytologic documentation of recurrence is required in patients who were
             previously completely resected

          -  Advanced Disease: Stage IIIB because of malignant pleural or pericardial effusion or
             stage IV disease

          -  Patients must be ineligible for Avastin or decline treatment with Avastin

          -  Prior Treatment: No prior chemotherapy or treatment with an EGFR inhibitor is allowed;
             brain metastasis must be under control (patient neurologically stable)

          -  All Patients must have Measurable or Non-Measurable Disease: measurable disease is
             defined as at least one lesion that can be accurately measured in at least one
             dimension; the longest diameter of measurable lesions must be >= 20 mm with
             conventional techniques or >= 10 mm with spiral computed tomography (CT) scan;
             non-measurable disease includes the following:

               -  Bone lesions

               -  Brain metastasis or leptomeningeal disease

               -  Ascites

               -  Pleural/pericardial effusion

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

               -  Tumor lesions situated in a previously irradiated area

                    -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

                    -  Granulocytes >= 1,500/ul

                    -  Platelets >= 100,000/ul

                    -  Creatinine =< upper limit of normal (ULN)

                    -  Bilirubin =< 1.5 mg/dl

                    -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase
                       [AST]) =< 1.5 x ULN

                    -  Alkaline (Alk.) phosphatase (phos.) =< 2.5 x ULN

          -  Patients must provide verbal and written informed consent to participate in the study

        Exclusion Criteria:

          -  Patients who are pregnant or nursing because of significant risk to the fetus/infant

          -  Patients with neuropathy >= grade 2

          -  Patients with a psychiatric illness which would prevent the patient from giving
             informed consent

          -  Patients who are unable to take oral medications

          -  Women with child-bearing potential or men who are sexual partners of women with
             child-bearing potential who are not willing to practice adequate contraceptive
             measures