7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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 adenocarcinoma with curative intent.

1.2 Secondary Objectives

1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who undergo curative intent resection of pancreatic adenocarcinoma.

1.2.2 To evaluate secondary endpoints of disease response such as duration of overall survival and patterns of recurrence for patients with resectable pancreatic cancer who undergo this treatment regimen.

1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both in the preoperative and postoperative setting, and to explore correlations between plasma and tumor erlotinib concentrations.

1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride; Gemcitabine

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:

1. WBC > 3000/mm³,ANC > 1500/mm³, Platelets > 100,000 mm³

2. Calculated Creatinine Clearance > 50 ml/min,Serum Creatinine < 1.5 mg/dl

3. Bilirubin < 3.0 mg/dl; aspartate aminotransferase(AST) and alanine aminotransferase (ALT) < 3 x normal value

4. PT/PTT/international normalized ratio(INR) within normal Limits.

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