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RATIONALE: Pazopanib hydrochloride and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well giving pazopanib hydrochloride together with or without pemetrexed disodium works in treating patients with stage III or stage IV non-squamous non-small cell lung cancer previously treated with bevacizumab.
- To estimate the disease-control rate (complete response [CR] + partial response [PR] + stable disease lasting ≥ 12 weeks as defined by RECIST criteria) of pazopanib hydrochloride with vs without pemetrexed disodium in patients with stage IIIB/IV non-squamous non-small cell lung cancer who progressed on first-line therapy containing bevacizumab as defined by RECIST criteria.
- To estimate the combined response rate (CR + PR) in these patients according to RECIST criteria.
- To estimate the progression-free survival and overall survival of these patients.
- To evaluate the safety and tolerability of treatment using the NCI CTCAE version 4.0.
- To explore potential correlations between blood biomarkers and clinical benefit.
OUTLINE: This is a multicenter study. Patients who have been treated with prior pemetrexed disodium are assigned to group 1 and patients who have not been treated with pemetrexed disodium are assigned to group 2.
- Group 1 (pazopanib hydrochloride alone): Patients receive oral pazopanib hydrochloride on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Group 2 (pazopanib hydrochloride and pemetrexed disodium): Patients receive oral pazopanib hydrochloride on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for biomarker analysis.
After completion of study therapy, patients are followed up every 2 months for 2 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
pazopanib hydrochloride, pemetrexed disodium
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:09:29-0400
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