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

Primary Purpose

Gastro Oesophageal Cancer

Status

Completed

Phase

Phase 2

Locations

Ireland

Study Type

Interventional

Intervention

Epirubicin

Oxaliplatin

Capecitabine

Docetaxel

About this trial

This is an interventional treatment trial for Gastro Oesophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mercy University Hospital
Beaumont Hospital
Mater Misericordiae University hospital & Mater Private Hospital
St James's Hospital
The Adelaide and Meath Hospital
Waterford Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Epirubicin, Oxaliplatin, Capecitabine

Docetaxel, Oxaliplatin

Arm Description

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 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

Outcomes

Primary Outcome Measures

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 Outcome Measures

In addition we will examine the effect of treatment on time to progression.

To examine the associated toxicity from treatment

To examine the effect of treatment on survival

To examine the effect of treatment on Quality of life.

Full Information

NCT ID

NCT01710592

First Posted

October 15, 2012

Last Updated

January 8, 2013

Sponsor

Cancer Trials Ireland

1. Study Identification

Unique Protocol Identification Number

NCT01710592

Brief Title

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

Acronym

ELECT

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Trials Ireland

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastro Oesophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epirubicin, Oxaliplatin, Capecitabine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Docetaxel, Oxaliplatin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Primary Outcome Measure Information:

Title

Time Frame

Two Years

Secondary Outcome Measure Information:

Title

In addition we will examine the effect of treatment on time to progression.

Time Frame

Two Years

Title

To examine the associated toxicity from treatment

Time Frame

2 years

Title

To examine the effect of treatment on survival

Time Frame

2 years

Title

To examine the effect of treatment on Quality of life.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Eatock, Dr

Organizational Affiliation

Cancer Trials Ireland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mercy University Hospital

City

Cork

Country

Ireland

Facility Name

Beaumont Hospital

City

Dublin

Country

Ireland

Facility Name

Mater Misericordiae University hospital & Mater Private Hospital

City

Dublin

Country

Ireland

Facility Name

St James's Hospital

City

Dublin

Country

Ireland

Facility Name

The Adelaide and Meath Hospital

City

Dublin

Country

Ireland

Facility Name

Waterford Regional Hospital

City

Waterford

Country

Ireland

12. IPD Sharing Statement

Learn more about this trial

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

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