A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer.
- To evaluate the efficacy of lapatinib ditosylate and capecitabine as first-line
therapy, in terms of overall survival, in patients with metastatic pancreatic cancer.
- 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
- To determine the intra-tumoral expression of ErbB1 (EGFR) and ErbB2 (HER2/neu) in these
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month survival rate
Ray McDermott, MD
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Ireland: Irish Medicines Board