Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

PRIMARY OBJECTIVES: I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid tumors. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when administered concomitantly. II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine and oxaliplatin. III. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria, in these patients. TERTIARY OBJECTIVES: I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood mononuclear cells secondary to treatment with ABT-888. II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and capecitabine and the relation to treatment side effects. OUTLINE: This is a dose-escalation study of veliparib. Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection at baseline and periodically during study for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies. After completion of study therapy, patients are followed up for 30 days.