Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer
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.
Drug: lapatinib ditosylate
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer.|
- 6-month survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression-free survival (PFS) will be measured as the number of days between patient's enrolment and his or her date of progression of disease. Patients who are still living six months after the last patient has been enrolled will be censored for the analyses, using the number of days between enrolment and the date of last follow-up. Disease progression will be determined according to definitions established in the modified response evaluation criteria in solid tumours (RECIST) (refer to Appendix G). For patients with non-measureable tumours disease progression will be determined by the treating physician in consultation with the Chief investigator for the study.
- Overall response rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]The overall response rate will be an aggregation of the complete responses and partial responses. For patients to be given the status of complete response or partial response a confirmatory disease assessment should be performed no less than four weeks after the criteria for response are first met.
- Clinical benefit [ Time Frame: 6 months ] [ Designated as safety issue: No ]A patient will be regarded as` having experienced clinical benefit if they have shown a complete response, a partial response, or stable disease for at least six months.
- Safety and tolerability [ Time Frame: Throughout course of study ] [ Designated as safety issue: Yes ]
- Tumour biomarker analysis [ Time Frame: Currently ongoing ] [ Designated as safety issue: No ]Characterising the patient population by determination of intra-tumoural expression of ErbB1 (EGFR) and ErbB2 (Her2/neu).Seeking pilot information as to the intra-tumoural expression of markers of tumour resistance and sensitivity to treatment. Proteomic analysis of serum samples for potential markers.
|Study Start Date:||January 2009|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Capecitabine and Lapatinib||Drug: capecitabine Drug: lapatinib ditosylate|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962312
|Cork University Hospital|
|Mercy University Hospital|
|Dublin, Ireland, 9|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|Mater Private Hospital|
|Dublin, Ireland, 7|
|St. James's Hospital|
|Dublin, Ireland, 8|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|University College Hospital|
|Principal Investigator:||Ray McDermott, MD||Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|