A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
- Conditions
- Gastro Oesophageal Cancer
- Interventions
- Registration Number
- NCT01710592
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced gastro-oesophageal cancer, their role, however, in the management of this disease remains unclear. Furthermore it is unclear whether this disease is optimally treated with a combination of two or three cytotoxic drugs. This trial aims to determine whether the combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the comparator arm for this evaluation.
Primary Objective:
Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer.
Secondary Objective:
To examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.
- Detailed Description
This is a randomised two-arm parallel group phase II study. 140 patients will be recruited over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and Oxaliplatin (EITax).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
- No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if >12 months previously).
- Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (>3 admissions for infective exacerbation in past 12 months) etc.
- ECOG performance status ≤ 2.
- Age ≥ to 18.
- Life expectancy ≥ 3 months
- Adequate renal, hepatic and bone marrow function
- Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).
- Liver function tests:
Bilirubin ≤ 1.0 x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN,Haemoglobin > 10.0 g/dl, Absolute neutrophil count >1.5 x 109 /L, Platelet count > 100 x109/L.
•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Symptoms or signs of peripheral neuropathy.
- Patients known to have second or third degree heart block.
- Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
- Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
- Pregnant or nursing.
- Female of child-bearing potential, or male partner of female of child bearing potential not taking adequate contraceptive precautions.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel, Oxaliplatin Oxaliplatin * Docetaxel 20mg/m2 (days 1, 8 \& 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel) * Oxaliplatin 85mg/m2 (days 1 \& 15)in 250mls of 5% dextrose. i.v. over 2 hours * 6 x 4-weekly cycle Epirubicin, Oxaliplatin, Capecitabine Oxaliplatin * Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle Epirubicin, Oxaliplatin, Capecitabine Epirubicin * Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle Epirubicin, Oxaliplatin, Capecitabine Capecitabine * Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle Docetaxel, Oxaliplatin Docetaxel * Docetaxel 20mg/m2 (days 1, 8 \& 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel) * Oxaliplatin 85mg/m2 (days 1 \& 15)in 250mls of 5% dextrose. i.v. over 2 hours * 6 x 4-weekly cycle
- Primary Outcome Measures
Name Time Method Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer Two Years
- Secondary Outcome Measures
Name Time Method To examine the effect of treatment on Quality of life. 2 years In addition we will examine the effect of treatment on time to progression. Two Years To examine the effect of treatment on survival 2 years To examine the associated toxicity from treatment 2 years
Trial Locations
- Locations (6)
Mercy University Hospital
🇮🇪Cork, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
Mater Misericordiae University hospital & Mater Private Hospital
🇮🇪Dublin, Ireland
St James's Hospital
🇮🇪Dublin, Ireland
The Adelaide and Meath Hospital
🇮🇪Dublin, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland