Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy

Inclusion Criteria:

• histologically or cytologically confirmed NSCLC not amenable to surgery or radiotherapy of curative intent
• locally advanced or metastatic Stage IIIb (with N3 supraclavicular or T4 for pleural effusion) or IV NSCLC
• no prior chemotherapy
• measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000)
• men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy

Exclusion Criteria:

• have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• have symptomatic brain metastases
• have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
• are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
• are unable or unwilling to take steroids
• are unable or unwilling to take folic acid or vitamin B12 supplementation
• have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry

• have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:

  • congestive heart failure or angina pectoris, except if it is medically controlled
  • previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
  • active infection requiring iv antibiotics
  • active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
  • superior vena cava syndrome