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Trial registered on ANZCTR


Registration number
ACTRN12606000181505
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
17/05/2006
Date last updated
16/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
ATTAX 2
Scientific title
A Phase II study evaluating tumour response of Cetuximab (ErbituxTM) plus weekly docetaxel chemotherapy in docetaxel refractory patients with advanced oesophago-gastric cancer
Secondary ID [1] 262 0
Australasian Gastro-Intestinal Trials Group: AG0603G-Ext
Universal Trial Number (UTN)
Trial acronym
ATTAX 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced oesophago-gastric cancer post docetaxel failure (second line treatment) 1154 0
Condition category
Condition code
Cancer 1235 1235 0 0
Stomach
Cancer 1236 1236 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly docetaxel (30mg/m2 on day 1 and day 8 of a 3 week cycle) plus Cetuximab (initial dose 400mg/m2 over 2 hours followed by weekly doses of 250mg/m2). Treatment will continue for 8 cycles (24 weeks) or until tumour progression.
Intervention code [1] 563 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1673 0
To evaluate tumour response to cetuximab plus docetaxel in patients with docetaxel refractory advanced oesophago-gastric cancer.
Timepoint [1] 1673 0
Tumour assessments will be performed every 6 weeks during treatment.
Secondary outcome [1] 2997 0
Toxicity of cetuximab plus docetaxel .
Timepoint [1] 2997 0
Evaluated at the end of every treament cycle (3 weeks).
Secondary outcome [2] 2998 0
To determine progression free and overall survival patients.
Timepoint [2] 2998 0
Followed up every 12 weeks after treatment completion, until tumour progression or patient death.
Secondary outcome [3] 2999 0
To estimate improvement in symptom control (performance status and weight gain) and quality of life (QoL).
Timepoint [3] 2999 0
QoL will be assessed 3 weekly for 12 weeks, then 6 weekly until treatment ceases.

Eligibility
Key inclusion criteria
a) Participation in the ATTAX studyb) Progression during ATTAX or within 6 months of docetaxel based chemotherapy as assessed using RECIST criteria.c) Consent has been provided for EGFR testing (any level of EGFR expression including EGFR negative tumours is allowed)d) WHO performance status of 0, 1 or 2 (Patients who are PS 2 should have serum albumin >30 g/L).e) Adequate bone marrow function with platelets > 100 X 109/l, and neutrophils > 1.5 X 109/l.f) Normal renal function, with serum creatinine <1.5x upper limit institutional normal range.g) Adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range and ALT/AST <2.5x upper limit of normal range.h) No concurrent uncontrolled medical conditions.i) Negative pregnancy test and adequate contraceptive precautions if relevant.j) Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol.b) Metastatic disease to the central nervous system. If CNS metastases are suspected they should be fully investigated by CT scan, MRI scan or CSF cytology.c) Allergy or hypersensitivity to docetaxel.d) Pregnancy or breast feeding.e) Clinical evidence of >grade 2 peripheral neuropathy, ie. affecting activities of daily living.f) Clinically significant cardiac disease comprising recent myocardial infarction, unstable angina or cardiac failure.g) Participation in any investigational drug study within the previous 4 weeks, except for ATTAX.h) Previous exposure to EGFR-targeting therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable as trial is open label with one treatment arm
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1352 0
Commercial sector/Industry
Name [1] 1352 0
Merck Serono
Country [1] 1352 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Gastro-Intestinal Trials Group
Address
92-94 Parramatta Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 1195 0
University
Name [1] 1195 0
NHMRC Clinical Trials Centre
Address [1] 1195 0
92-94 Parramatta Road, Camperdown, NSW, 2050
Country [1] 1195 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2703 0
Royal North Shore Hospital
Ethics committee address [1] 2703 0
Ethics committee country [1] 2703 0
Australia
Date submitted for ethics approval [1] 2703 0
Approval date [1] 2703 0
07/11/2005
Ethics approval number [1] 2703 0
AG0603-Ext
Ethics committee name [2] 2704 0
Bankstown-Lidcombe Hospital
Ethics committee address [2] 2704 0
Ethics committee country [2] 2704 0
Australia
Date submitted for ethics approval [2] 2704 0
Approval date [2] 2704 0
21/03/2005
Ethics approval number [2] 2704 0
AG0603-Ext
Ethics committee name [3] 2705 0
Frankston Hospital
Ethics committee address [3] 2705 0
Ethics committee country [3] 2705 0
Australia
Date submitted for ethics approval [3] 2705 0
Approval date [3] 2705 0
12/12/2005
Ethics approval number [3] 2705 0
AG0603-Ext
Ethics committee name [4] 2706 0
Austin Health
Ethics committee address [4] 2706 0
Ethics committee country [4] 2706 0
Australia
Date submitted for ethics approval [4] 2706 0
Approval date [4] 2706 0
01/03/2005
Ethics approval number [4] 2706 0
AG0603-Ext
Ethics committee name [5] 2707 0
Monash Medical Centre
Ethics committee address [5] 2707 0
Ethics committee country [5] 2707 0
Australia
Date submitted for ethics approval [5] 2707 0
Approval date [5] 2707 0
13/07/2005
Ethics approval number [5] 2707 0
AG0603-Ext
Ethics committee name [6] 2708 0
Border Medical Oncology
Ethics committee address [6] 2708 0
Ethics committee country [6] 2708 0
Australia
Date submitted for ethics approval [6] 2708 0
Approval date [6] 2708 0
15/12/2004
Ethics approval number [6] 2708 0
AG0603-Ext
Ethics committee name [7] 2709 0
Princess Alexandra Hospital
Ethics committee address [7] 2709 0
Ethics committee country [7] 2709 0
Australia
Date submitted for ethics approval [7] 2709 0
Approval date [7] 2709 0
19/10/2005
Ethics approval number [7] 2709 0
AG0603-Ext
Ethics committee name [8] 2710 0
Sir Charles Gairdner Hospital
Ethics committee address [8] 2710 0
Ethics committee country [8] 2710 0
Australia
Date submitted for ethics approval [8] 2710 0
Approval date [8] 2710 0
19/05/2005
Ethics approval number [8] 2710 0
AG0603-Ext

Summary
Brief summary
New approaches to the treatment of advanced oesophago-gastric cancer are likely to involve biologically relevant targets, which either alone or in combination with chemotherapy, may result in prolonged disease stabilisation or tumour response, hence improving patient outcomes (QOL, symptom control and survival). One such biological target is the epidermal growth factor receptor (EGFR).

The role of EGFR in advanced oesophago-gastric cancer is unknown although high EGFR expression is known to occur in around 60-80% of patients and is associated with an adverse prognosis and resistance to chemotherapy. Furthermore, responses have been observed using agents targeting EGFR in advanced oesophago-gastric cancer.

Cetuximab is a well-characterised, relatively non-toxic antibody directed against EGFR. Cetuximab has been used as a single agent and in combination with chemotherapy in a variety of cancers. Hence it seems appropriate to examine the role of cetuximab in advanced oesophago-gastric cancer. Considering the fact that docetaxel based regimens appear highly active in advanced oesophago-gastric cancer, there is a strong rationale for combining docetaxel with cetuximab. Synergy between taxanes and other agents targeting the family of EGFRs has been observed in other types of cancer.

Therefore we have developed this Phase II study of cetuximab plus docetaxel in patients with advanced (recurrent or metastatic) oesophago-gastric cancer who are refractory to docetaxel therapy.
This is an optional extension study for patients who have participated in ATTAX (AG0603) (all of whom receive docetaxel) and who have progressed either during or within 6 months of docetaxel based chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35256 0
Address 35256 0
Country 35256 0
Phone 35256 0
Fax 35256 0
Email 35256 0
Contact person for public queries
Name 9752 0
Ms. Burcu Cakir
Address 9752 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9752 0
Australia
Phone 9752 0
+61 2 95625000
Fax 9752 0
+61 2 95625094
Email 9752 0
[email protected]
Contact person for scientific queries
Name 680 0
Dr Niall Tebbutt
Address 680 0
Department of Medical Oncology
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 680 0
Australia
Phone 680 0
+61 3 94963217
Fax 680 0
+61 3 94576698
Email 680 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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