A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)

Pancreatic Cancer Clinical Trial

— PERU  

Official title:

A Multicentre Randomised Phase II Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01050426
• Other study ID #: 3065
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2009
• Last updated: October 13, 2016
• Start date: March 2009
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.

Description:

Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer. Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas.

• Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta.

• Performance status 0-2

• No evidence of metastatic disease as determined by CT scan/ other investigations

• Adequate bone marrow function with platelets>100^9/l; WBC>3x10^9/l;neutrophils> 1.5x10^9/l

• Serum bilirubin ,1.5 x ULN and transaminases < 2.5 x ULN

• Calculated/measured GFR >50ml/min

• No concurrent uncontrolled medical condition

• No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years

• Life expectancy > 3months

• Adequate contraceptive precautions

• Informed written consent

Exclusion Criteria:

• medical or psychiatric conditions that compromise the patient's ability to give informed consent

• Presence of met. disease

• Concurrent uncontrolled medical conditions

• Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer.

• Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry

• Adjuvant RT with/without chemo for pancreatic cancer.

• Pregnancy/breast feeding

• Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract.

• Patients with a known hypersensitivity to 5-FU or with a DPD deficiency.

• Clinically significant CVD

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• UFT, Leucovorin
UFT 300mg/m2/day in 3 equal doses and Leucovorin 90mg/day in 3 divided doses per day given daily on the days of radiotherapy only (30 days in total)
• UFT/ Leucovorin + Cetuximab + Radiotherapy
UFT 300mg/m2 + LV 90mg/day on days of RT only (30 days in total), Cetuximab 400mg/m2 week 1, thereafter 250mg/m2 weeks 2-6

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	Royal Surrey County Hospital NHS Trust	Guildford	Surrey
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Poole Hospital NHS Trust	Poole
United Kingdom	The Royal Marsden NHS Trust	Sutton	Surrey
United Kingdom	Kent Oncology Centre	Tunbridge Wells	Maidstone
United Kingdom	Clatterbridge Centre for Oncology NHS Foundation Trust	Wirral

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Merck Serono International SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One year overall survival, measured from the date of registration.		one year	No
Secondary	Progression free survival		three years	No
Secondary	Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer		three years	Yes
Secondary	Objective response rate		three years	No
Secondary	Pattern of failure		up to 3 years	Yes
Secondary	Quality of life		up to 3 years	No
Secondary	Evaluation of molecular and genetic predictors of response to anti-EGFR treatment		up to 3 years	No
Secondary	Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.		up to 3 years	No
Secondary	Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer.		up to 3 years	No