Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery.
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma|
- Overall survival at 2 years [ Designated as safety issue: No ]
- Resection rate [ Designated as safety issue: No ]
- Relapse/progression-free survival [ Designated as safety issue: No ]
- Adverse event profile [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Molecular and genetic profiles [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
- To estimate the proportion of patients with resectable adenocarcinoma of the pancreas alive at 2 years from the date of study registration after treatment with neoadjuvant and adjuvant gemcitabine hydrochloride and erlotinib hydrochloride plus pancreatectomy.
- To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor [R0/R1]) after neoadjuvant treatment with gemcitabine hydrochloride and erlotinib hydrochloride.
- To estimate the time to disease progression/relapse in these patients.
- To evaluate the rate of R0, R1, and R2 resections in these patients.
- To evaluate the toxicity profile and feasibility of this regimen in these patients.
- To evaluate response rates in patients treated with this regimen.
- To identify molecular predictors of response to this regimen.
- To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy:Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.
- Surgery:At 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy.
- Adjuvant therapy:Beginning 5-10 weeks after surgery, patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy.
Patients undergo blood and tumor tissue sample collection for correlative laboratory studies. Studies include assessment of epithelial-mesenchymal transition (EMT) markers, analysis of EGFR intron 1 polymorphism, and identification of genetic profiles by RNA analysis.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.