7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic, Cancer, Assay, Biomarkers
Eligibility Criteria
Inclusion Criteria:
.Histologic or cytologic confirmation of pancreatic ductal adenocarcinoma.
- Pancreatic cancer must be surgically resectable: a) no evidence of distant metastasis; b) clear fat plane around the celiac and superior mesenteric arteries; c) patent portal and superior mesenteric veins
- No evidence of post-resection distant metastasis
- Pathologic confirmation of R0/R1 status following surgical resection
- Age ≥ 19 years
- Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required.
- Patient should be able to understand and offer signed written informed consent prior to study entry.
- No prior receipt of chemotherapy or radiotherapy
- Patients must demonstrate a Eastern Cooperative Oncology Group(ECOG) P.S. of 0 or 1
- End Organ function must be adequate meeting the below criteria at baseline:
White Blood Cell Count (WBC)> 3000/mm3, absolute neutrophil count(ANC)> 1500/mm3, Platelets>100,000mm3 Calculated creatinine clearance >50 ml/min, normal serum creatinine (mg/dL) (if calculated Crcl <50 ml/min, Crcl should measured and be > 50 ml/min) Bilirubin <3.0 mg/dL (patients with obstructive jaundice require preoperative endoscopic biliary stenting if total bilirubin >3.0 mg/dl) prothrombin time(PT) /partial thromboplastin time(PTT) below the upper limit of normal
Exclusion Criteria:
- Diagnosis of active (treated in past 5 years) concomitant malignancy with exception of non-melanotic skin cancer
- Transplant patients or patients receiving immunosuppression
- Presence of an underlying disease state associated with active bleeding or a past medical history of coagulopathy
- New York Heart Association Class IV congestive heart failure
- Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
- History of non-compliance with prescribed medical care
Post-Operative Phase Inclusion
- No Evidence of Post-Resection Distant Metastasis
- Pathological confirmation of R0/R1 status following Surgical resection
- Patient must demonstrate a post-operative performance status of 0 or 1.
End Organ function must be adequate, meeting the below criteria at baseline:
- WBC > 3000/mm³,ANC > 1500/mm³, Platelets > 100,000 mm³
- Calculated Creatinine Clearance > 50 ml/min,Serum Creatinine < 1.5 mg/dl
- Bilirubin < 3.0 mg/dl; aspartate aminotransferase(AST) and alanine aminotransferase (ALT) < 3 x normal value
PT/PTT/international normalized ratio(INR) within normal Limits.
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Sites / Locations
- University of Alabama at Birmingham,Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Eroltinib added to standard of care
150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles