Gastro Oesophageal Cancer
Conditions
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).
Interventions
DRUGEpirubicin
DRUGOxaliplatin
DRUGCapecitabine
DRUGDocetaxel
Sponsors
Cancer Trials Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| In addition we will examine the effect of treatment on time to progression. | Two Years |
| To examine the associated toxicity from treatment | 2 years |
| To examine the effect of treatment on survival | 2 years |
| To examine the effect of treatment on Quality of life. | 2 years |
Countries
Ireland
Outcome results
None listed