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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by Royal Marsden NHS Foundation Trust
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01050426
First received: December 21, 2009
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Other: UFT, Leucovorin
Other: UFT/ Leucovorin + Cetuximab + Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • One year overall survival, measured from the date of registration. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Pattern of failure [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluation of molecular and genetic predictors of response to anti-EGFR treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
UFT/LV + RT
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)
Active Comparator: Group 2
UFT/LV + RT + Cetuximab
Other: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050426

Contacts
Contact: Ian Chau ian.chau@rmh.nhs.uk
Contact: Diana Tait diana.tait@rmh.nhs.uk

Locations
United Kingdom
Kent Oncology Centre Active, not recruiting
Tunbridge Wells, Maidstone, United Kingdom, ME16 9QQ
Royal Surrey County Hospital NHS Trust Active, not recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
The Royal Marsden NHS Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Ian Chau       ian.chau@rmh.nhs.uk   
Principal Investigator: Ian Chau         
Aberdeen Royal Infirmary Active, not recruiting
Aberdeen, United Kingdom, AB25 2ZN
The Royal Bournemouth Hospital Active, not recruiting
Bournemouth, United Kingdom
Christie Hospital NHS Foundation Trust Active, not recruiting
Manchester, United Kingdom, M20 4BX
Poole Hospital NHS Trust Active, not recruiting
Poole, United Kingdom, BH15 2JB
Clatterbridge Centre for Oncology NHS Foundation Trust Active, not recruiting
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Merck Serono International SA
Investigators
Principal Investigator: Ian Chau The Royal Marsden NHS Trust
  More Information

No publications provided

Responsible Party: Ian Chau, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01050426     History of Changes
Other Study ID Numbers: 3065
Study First Received: December 21, 2009
Last Updated: January 14, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Cetuximab
Gemcitabine
Leucovorin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 22, 2014