Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer
Eligibility Criteria
Eligibility Criteria:
Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process.
NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible.
Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging:
- 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. Patients must meet all objective imaging criteria outlined above.
- ≥ 18 years of age
- ECOG/Zubrod performance status of 0 or 1
- Baseline weight loss ≤ 15% of premorbid weight
Patient must have adequate hematologic, renal, and hepatic function as defined by:
- WBC ≥ 2,000 cells/mm³
- ANC ≥ 1,500 cells/mm³
- Platelets ≥ 100,000 cells/mm³
- Serum bilirubin ≤ 2.5 mg/dL
- Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min (24 hour urine collection)
- ALT < 2.5 times upper limit of normal (ULN)
- AST < 2.5 times ULN
- Albumin ≥ 3.2 g/dl
No history of the following:
- Prior EGFR targeted therapy or therapy for pancreatic cancer
- Active infection requiring intravenous antibiotics at the time of registration
- Non-pregnant and non-breast feeding. Female participants of child bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth control while receiving study therapy.
- No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)
Sites / Locations
- Rebecca and John Moores UCSD Cancer Center
- Kaiser Permanente Medical Center - Los Angeles
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- St. Vincent's Medical Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- St. Francis Hospital Cancer Care Services
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- St. Agnes Hospital Cancer Center
- University of Mississippi Cancer Clinic
- Methodist Estabrook Cancer Center
- NYU Cancer Institute at New York University Medical Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Charles F. Kettering Memorial Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Providence Cancer Center at Providence Portland Medical Center
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Surgical Oncology Associates
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
Neoadjuvant therapy + Surgery + Adjuvant therapy
As part of 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. Within 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy and patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post surgery.