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.
Verified January 2010 by Royal Marsden NHS Foundation Trust
Sponsor:
Royal Marsden NHS Foundation Trust
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
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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:
Drug Information available for:
Leucovorin calcium
Levoleucovorin
Gemcitabine
Gemcitabine hydrochloride
Capecitabine
Cetuximab
U.S. FDA Resources
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
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 Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Leucovorin Levoleucovorin Gemcitabine Capecitabine Cetuximab Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 22, 2013