Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with metastatic pancreatic cancer.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00962312
• Study type: Interventional
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Status: Completed
• Phase: Phase 2
• Start date: January 2009