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

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.

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).

Eligibility criteria:
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