Status:
COMPLETED
Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
OSI Pharmaceuticals
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Drugs u...
Detailed Description
This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00733746
Start Date
April 1 2009
End Date
June 15 2019
Last Update
October 21 2019
Active Locations (24)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
3
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
4
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606