Stage IV Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed (Alimta) and Erlotinib (Tarceva) vs Single Agent Pemetrexed (Alimta®) in Patients With Progressive or Recurrent Non-small Cell Lung Cancer (NSCLC)
This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective with or without erlotinib hydrochloride in treating non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate progression free survival (PFS) in the schedule-modulated concomitant
administration of erlotinib (erlotinib hydrochloride) and pemetrexed (pemetrexed disodium),
and in single agent pemetrexed in patients with advanced non-small cell lung cancer (NSCLC)
as second-line chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate antitumor objective response rate (complete response [CR] + partial response
[PR]) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
II. To evaluate disease control rate (response rate + stable disease, i.e., CR+PR+ stable
disease [SD]) and duration of response.
III. To evaluate median time to progression (TTP) and overall survival (OS). IV. To evaluate
the safety profile of concurrent pemetrexed and erlotinib versus single agent pemetrexed.
TERTIARY OBJECTIVES:
i. To determine several molecular and cellular biomarkers in the tumors, the skin and the
serum that are predictive of the efficacy of pemetrexed and erlotinib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride orally
(PO) once daily (QD) on days 2-17. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
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