Trial Information

Summary: Randomized Phase II Study of First-Line Treatment with Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients with Stage (IIIB/IV) Non-Small Cell Lung Cancer

This trial is for patients age 70 years and older who have received 1 treatment for their lung cancer, and this treatment must have been at least 1 year ago.

Inclusion Criteria

• Histologic or cytologic diagnosis of stage NSCLC
• Age = 70 years
• ECOG Performance status of 0-2
• Adequate end-organ function Patients may have received 1 prior treatment in the adjuvant setting, but time since prior chemotherapy must be = 1 year. Although the protocol specifically says adjuvant therapy, we believe neo-adjuvant is similar and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant (post-operative) therapy are similar and should not be distinguished. Therefore, patients may have received 1 prior treatment in the neo-adjuvant setting as well.
• Treated brain metastases are eligible provided the patient is asymptomatic and meets the above criteria, including PS.
• Measurable disease (RECIST criteria)
• Ability to give informed consent

Exclusion Criteria

• No history of severe hypersensitivity to gemcitabine.
• Not incompletely healed from previous oncologic or other major surgery.
• No patients who are pregnant or breast feeding (women of childbearing potential are not expected to be enrolled in this study given number 2)
• No patients with severe co-morbid illness.
• No patients unable to participate in the QOL assessments.

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Trial listings updated: June 1, 2008 at 6:32:48 AM