Non-Small Cell Lung Cancer Clinical Trial
Official title:
Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for clinical benefit to Avastin. Preliminary studies show that there are several observations that support the concept of metronomic chemotherapy with or without the combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown to enhance the clinical endpoints of the study (response rate and progressive-free survival). Proof of metronomic scheduling requires the development of appropriate intermediate surrogate markers. Several markers will be assessed.
This is a non-randomized, open-label, pilot Phase II study of metronomic chemotherapy plus
Avastin in chemo naïve subjects with advanced non-squamous, non-small cell carcinoma of the
lung. The primary endpoint of this study is to assess the overall progression-free survival.
Subjects will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly
for 3 out of 4 weeks, and Avastin will be administered every 2 weeks. Treatment with
metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment
will be evaluated every 8 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles
unless there is evidence of disease progression, intolerable toxicity, or withdrawal of
consent. Maintenance therapy with Avastin will then continue until disease progression,
intolerable toxicity or withdrawal of consent.
Potential biologic parameters to monitor anti-tumor activity of metronomic chemotherapy will
be evaluated in 10 subjects. These biomarkers include: sequential determination of blood
levels of VEGF, VEGFR2, thrombospondin-1, E-selectin, ICAM-1, and circulating endothelial
cells and endothelial precursor cells.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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