Clinical trial NCT01710592: A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
Official title: A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastro Oesophageal Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2012-10-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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
timeFrame: Two Years
Secondary outcomes:
measure: In addition we will examine the effect of treatment on time to progression.
timeFrame: Two Years
measure: To examine the associated toxicity from treatment
timeFrame: 2 years
measure: To examine the effect of treatment on survival
timeFrame: 2 years
measure: To examine the effect of treatment on Quality of life.
timeFrame: 2 years
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Mercy University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University hospital & Mater Private Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: The Adelaide and Meath Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
affiliation: Cancer Trials Ireland
name: Martin Eatock, Dr
role: PRINCIPAL_INVESTIGATOR
References: