A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

NCT ID: NCT01710592

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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).

Conditions

Gastro Oesophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epirubicin, Oxaliplatin, 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

Group Type: ACTIVE_COMPARATOR

Epirubicin

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Docetaxel, 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

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Interventions

Epirubicin

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Eatock, Dr

Role: PRINCIPAL_INVESTIGATOR

Cancer Trials Ireland

Locations

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

Countries

Ireland

Other Identifiers

ICORG 06-05

Identifier Type: -

Identifier Source: org_study_id

NCT00806949

Identifier Type: -

Identifier Source: nct_alias