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

NCT00841035 | Terminated Phase 2 Results DMC

• 1 other identifier: F080718006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic; Cancer; Assay; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.

  It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.

  During the trial only

Secondary Outcomes (1)

• The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.

  End of the study

Study Arms (1)

Eroltinib added to standard of care

EXPERIMENTAL

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

Drug: erlotinib

Interventions

erlotinib DRUG

Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib 100 mg daily 6 month/6 chemotherapy cycles. Gemcitabine 1000 m2 weekly after surgery for 6 cycles.

Also known as: Tarceva

Eroltinib added to standard of care

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Alabama at Birmingham,Comprehensive Cancer Center

Birmingham, Alabama, 35294-0016, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination by sponsor and No good clinical data was analyzed to the early termination of the study.

Results Point of Contact

• Title: Research Nurse Supervisor of Clinical trials
• Organization: University of Alabama at Birmingham

jhrichardson@uabmc.edu

(205)975-0450

Study Officials

• Juan P Arnoletti, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of section of Surgical Oncology

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 19, 2017
• Results First Posted: October 6, 2014

Record last verified: 2017-04

Locations

US (1)