Lung Cancer Clinical Trial
Official title:
Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating
patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
- Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar
carcinoma treated with pemetrexed disodium.
Secondary
- Evaluate the progression-free survival of patients treated with this drug.
- Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the
subset of patients with measurable disease treated with this drug using standard RECIST
criteria and computer assisted image analysis.
- Evaluate frequency and severity of toxicities in patients treated with this drug.
- Perform molecular correlative studies on patient tissue to investigate potential
predictors of efficacy. (This will not be completed as this study was closed due to
poor accrual.)
OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib
(yes vs no).
Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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