A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer.

Brief Summary

Detailed Description

OBJECTIVES: Primary * To evaluate the efficacy of lapatinib ditosylate and capecitabine as first-line therapy, in terms of overall survival, in patients with metastatic pancreatic cancer. Secondary * To evaluate the progression-free survival of patients treated with this regimen. * To evaluate the overall response rate (complete and partial responses) in patients treated with this regimen. * To evaluate the clinical benefit (complete response, partial response, or stable disease for ≥ 6 months) of this regimen in these patients. * To evaluate the qualitative and quantitative toxicity associated with this regimen in these patients. * To determine the intra-tumoral expression of ErbB1 (EGFR) and ErbB2 (HER2/neu) in these patients. * To seek pilot information on the intra-tumoral expression of markers of tumor resistance and sensitivity to treatment, including resistance drug pump expression and growth factor receptor expression. * To collect pre- and post-treatment serum samples from these patients for proteomic analyses to elucidate if any serum cancer marker profiles can be detected. OUTLINE: This is a multicenter study. Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6-12 weeks.

Primary Outcomes

Secondary Outcomes

• Progression-free survival(6 months)
• Overall response rate(up to 6 months)
• Clinical benefit(6 months)
• Safety and tolerability(Throughout course of study)
• Tumour biomarker analysis(Currently ongoing)