Status:
TERMINATED
7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
Brief Summary
1.1 Primary Objective To evaluate the effects of short course preoperative erlotinib treatment in a panel of predictive biomarkers from a group of patients who undergo resection of pancreatic adenoca...
Detailed Description
Our current clinical trial proposal includes a short course of pre-operative, single agent erlotinib followed by post-operative erlotinib-gemcitabine in a neo-adjuvant/adjuvant approach to the treatme...
Eligibility Criteria
Inclusion
- .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
- 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.
- \-
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00841035
Start Date
February 1 2009
End Date
July 1 2011
Last Update
May 19 2017
Active Locations (1)
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1
University of Alabama at Birmingham,Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-0016