A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (S1206/NCI Study Number 8811)
What is the purpose of this trial?
Phase II Portion Objectives: -To assess whether carboplatin/paclitaxel plus ABT-888 compared with carboplatin/paclitaxel plus placebo improves progression-free survival (PFS) in patients with unresectable Stage III NSCLC. -To compare overall survival (OS) in patients treated with carboplatin/paclitaxel and radiotherapy plus ABT-888 to those treated with carboplatin, paclitaxel and radiotherapy plus placebo. -To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate in the subset of patients with measurable disease by RECIST criteria -To assess the safety and toxicity profile of the regimen Tertiary Objectives: -To collect tumor tissue from pretreatment biopsies (archival samples) for biomarker studies, including PARP activity by measuring the levels of poly-ADPribose, ¥ã-H2AX, and mRNA expression levels of DNA repair enzymes such as ERCC1/XRCC1. -To collect blood samples for evaluation of PARP (peripheral blood mononuclear cells) and ¥ã-H2AX (circulating tumor cells) and other relevant future studies.
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- Southwest Oncology Group (SWOG)
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