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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01050426
Recruitment Status : Terminated (Data from other trials failed to demonstrate meaningful survival advantage)
First Posted : January 15, 2010
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 2009
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. One year overall survival, measured from the date of registration. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: three years ]
  2. 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 ]
  3. Objective response rate [ Time Frame: three years ]
  4. Pattern of failure [ Time Frame: up to 3 years ]
  5. Quality of life [ Time Frame: up to 3 years ]
  6. Evaluation of molecular and genetic predictors of response to anti-EGFR treatment [ Time Frame: up to 3 years ]
  7. Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. [ Time Frame: up to 3 years ]
  8. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050426


Locations
United Kingdom
Kent Oncology Centre
Tunbridge Wells, Maidstone, United Kingdom, ME16 9QQ
Royal Surrey County Hospital NHS Trust
Guildford, Surrey, United Kingdom, GU2 7XX
The Royal Marsden NHS Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Poole Hospital NHS Trust
Poole, United Kingdom, BH15 2JB
Clatterbridge Centre for Oncology NHS Foundation Trust
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

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01050426     History of Changes
Other Study ID Numbers: 3065
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

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