Pharmacogenomic & Phase II Study of Gemcitabine and Pemetrexed in Non-Small-Cell Lung Cancer.
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gemcitabine; Pemetrexed; Surgery
Intervention description: Gemcitabine (GemzarR) 1500 mg/m2; Pemetrexed (AlimtaR) 500 mg/m2; When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small-Cell Lung Cancer; resectable; NSCLC

Summary:

      This study will evaluate the efficacy and safety of chemotherapy given prior to having lung
      cancer surgically removed. Patients with resectable non-small cell lung cancer will receive
      gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical
      oncologist prior to each cycle of chemotherapy given. The medical oncologist will review
      patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients
      will then be evaluated with scans to determine response to chemotherapy and to determine if
      patient is a surgical candidate. These patients will then proceed to surgery to have the lung
      cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical
      oncologist every three months for two years, then every six months for three years to monitor
      for disease recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Microscopically confirmed non-small cell carcinoma of the lung, which may be confirmed
             at the initial bronchoscopy and mediastinoscopy, or by transthoracic needle biopsy.

          -  No prior therapy for lung cancer.

          -  Patients must have disease stages IB (T2N0M0), IIA (T1N1M0), IIB (T2N1M0 and T3N0M0),
             or IIIA (T3N1M0 and T1-3N2M0). Patients with 2 lesions in one lobe (T4) (Stage IIIB)
             are eligible.

          -  Patients must be deemed medically fit for surgical resection by a thoracic surgeon.

          -  Patients must have an ECOG performance status of Zero or One.

          -  Patients must have measurable or evaluable disease.

          -  Measurable Disease: Any mass reproducibly measurable in one diameter (RECIST
             criteria).

          -  Evaluable disease: Lesions apparent on chest CT, which do not meet the criteria for
             measurability. These include ill-defined masses associated with post obstructive
             changes.

          -  Age >18 years.

          -  Patient must be able to understand and sign the informed consent.

          -  Patients must be >12 weeks from prior major surgery, such as a coronary artery bypass
             graft.

        Exclusion Criteria:

          -  White blood cell count <3000/mm3

          -  Platelet count <100,000/mm3

          -  Hemoglobin <9.0 g/dl

          -  Creatinine >1.5 mg/dl

          -  Total bilirubin >1.5 mg/dl

          -  SGOT, SGPT, or AP >1.5 x upper limit of normal

          -  Metastatic disease (except peribronchial/hilar lymph nodes=N1 and
             ipsilateral/subcarinal mediastinal lymph nodes=N2) or malignant pleural effusion
             detected on preoperative evaluation. Non-malignant effusions are cytology negative,
             are non-bloody, and are transudates. Effusions visible only on CT and not large enough
             for safe thoracentesis will not result in ineligibility. Exudative effusions, even if
             cytologically negative are excluded. Pleural fluid is considered exudative if: the
             ratio of pleural fluid protein to serum protein is >0.5 or the ratio of pleural fluid
             LDH to serum to serum LDH >0.6 or Pleural fluid LDH is >200 IU/liter. A staging PET
             scan will be used to exclude patients. If there are multiple areas of FDG uptake
             outside the area of the primary tumor and the hilar and ipsilateral mediastinal lymph
             nodes, the patient will be excluded by virtue of having metastatic disease. If
             however, only one area shows an increase in FDG uptake, the area of concern will need
             further evaluation such as a biopsy to exclude metastatic disease.

          -  N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene) or T4
             primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging
             criteria (N3 as seen on CT or PET scan, which may be proven by mediastinoscopy at the
             investigators discretion).

          -  Pregnancy.

          -  Other active malignancy within 2 years with the exceptions of non-melanoma skin cancer
             and cervical carcinoma in situ.

          -  Psychologic, familial, sociologic, or geographic conditions, which do not permit
             biweekly medical follow-up and adherence to the study protocol.

          -  Prior radiation therapy for any cancer to the thorax.