Advanced (Inoperable locally advanced, metastatic or recurrent) , histologically verified adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophagogastric junction or stomach. MedDRA version: 9.1 Level: LLT Classification code 10017770 Term: Gastric carcinoma MedDRA version: 9.1 Level: LLT Classification code 10030155 Term: Oesophageal carcinoma
Conditions
Interventions
Trade Name: Vectibix
Product Name: Panitumumab
Product Code: AMG 954
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Product Name: Oxaliplatin
Pharm
Sponsors
Royal Marsden Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically verified inoperable locally advanced or metastatic adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach. •Slides of tumour tissue should be available •Uni-dimensionally measurable disease (CT or MRI as per RECIST). •No prior chemotherapy for advanced oesophago-gastric cancer (patients who have received prior adjuvant chemotherapy may be included if relapse has occurred 6 months or greater after completion of chemotherapy). •No prior radiotherapy other than previous adjuvant treatment, where relapse has occurred outside the radiotherapy fields. •Male/female patients aged =18 years. •WHO Performance status 0, 1 or 2. •Life expectancy of at least 3 months. •Completion of baseline quality of life questionnaire (EORTC QLQ C30). •Adequate left ventricular ejection fraction > 50% (determined by MUGA scan or ECHO). •Adequate bone marrow, renal and liver function •Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Tumours of squamous histology. •Patients with locally advanced oesophageal cancer suitable for definitive chemoradiotherapy. •Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease. •Previous chemotherapy, unless peri-operative or adjuvant therapy completed > 6 months prior to disease relapse. •Any radiotherapy or major surgery within 4 weeks prior to the start of study treatment. •Any prior treatment with an EGFR signal transduction directed therapy. •Clinically significant (i.e. active) cardiac disease •History of interstitial lung disease •Known peripheral neuropathy = Grade 1 •Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication •Known dihydropyrimidine dehydrogenase (DPD) deficiency. •known hypersensitivity to panitumumab, components of the EOX regimen, or any of the constituents of these agents. •Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection. •Other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial. •Female patients who may be pregnant or breastfeeding. Potential female patients of childbearing potential must have a negative pregnancy test within 7 days prior to randomization, or have had amenorrhea for more than 2 years. •Patients of child-bearing potential not consenting to use adequate contraceptive precautions or abstinence during the course of the study and for 6 months after the last study drug administration for females, and 1 month for males. •Any other malignancies within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether adding panitumumab to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the median overall survival of patients with advanced oesophago-gastric cancer.;Secondary Objective: To determine whether adding panitumumab to EOX chemotherapy for patients with advanced oesophago-gastric carcinoma improves the: 1. Response rate 2. Progression-free survival 3. Toxicity (according to CTCAE version 3) 4. Quality of life Whether biomarkers including EGFR expression and kirsten-ras oncogene mutation affect the response to treatment and primary and secondary outcomes.;Primary end point(s): Overall survival | — |
Countries
United Kingdom
Outcome results
None listed