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

NCT01050426 | Terminated Phase 2 DMC

• 1 other identifier: 3065
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• One year overall survival, measured from the date of registration.

  one year

Secondary Outcomes (8)

• Progression free survival

  three years

• 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

• Objective response rate

  three years

• Pattern of failure

  up to 3 years

• Quality of life

  up to 3 years

Study Arms (2)

Group 1

ACTIVE COMPARATOR

UFT/LV + RT

Other: UFT, Leucovorin

Group 2

ACTIVE COMPARATOR

UFT/LV + RT + Cetuximab

Other: UFT/ Leucovorin + Cetuximab + Radiotherapy

Interventions

UFT, Leucovorin OTHER

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)

Group 1

UFT/ Leucovorin + Cetuximab + Radiotherapy OTHER

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

Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Merck Serono International SA: collaborator

Study Sites (8)

Kent Oncology Centre

Royal Tunbridge Wells, Maidstone, ME16 9QQ, United Kingdom

Location

Royal Surrey County Hospital NHS Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

The Royal Marsden NHS Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Poole Hospital NHS Trust

Poole, BH15 2JB, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Tegafur; Leucovorin; Cetuximab; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Ian Chau

  The Royal Marsden NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: January 15, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

GB (8)