- 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.
- Histologically or cytologically confirmed adenocarcinoma of the pancreatic head or uncinate process
- No tumors of the pancreatic neck, body, or tail
- No evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma
- Localized, potentially resectable* tumor by chest x-ray or CT scan and abdominal CT scan or MRI, as defined by the following:
- No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery
- No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
- No evidence of visceral or peritoneal metastases NOTE: *Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible.
- ECOG or Zubrod performance status 0-1
- WBC ≥ 2,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 2.5 mg/dL
- ALT and AST ≤ 2.5 times upper limit of normal
- Albumin ≥ 3.2 g/dL
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Baseline weight loss ≤ 15% of premorbid weight
- No active infection requiring intravenous antibiotics
- No other malignancy within the past 5 years except for nonmelanoma skin cancer or in situ cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior EGFR-targeted therapy
- No prior therapy for pancreatic cancer
- No other concurrent investigational or commercial agents or therapies for pancreatic cancer
Last updated: 03/26/2012
NCT ID: NCT00733746