ATTAX 2
- Conditions
- Advanced oesophago-gastric cancer post docetaxel failure (second line treatment)Cancer - StomachCancer - Oesophageal (gullet)
- Registration Number
- ACTRN12606000181505
- Lead Sponsor
- Australian Gastro-Intestinal Trials Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate tumour response to cetuximab plus docetaxel in patients with docetaxel refractory advanced oesophago-gastric cancer.[Tumour assessments will be performed every 6 weeks during treatment.]
- Secondary Outcome Measures
Name Time Method Toxicity of cetuximab plus docetaxel .[Evaluated at the end of every treament cycle (3 weeks).];To determine progression free and overall survival patients.[Followed up every 12 weeks after treatment completion, until tumour progression or patient death.];To estimate improvement in symptom control (performance status and weight gain) and quality of life (QoL).[QoL will be assessed 3 weekly for 12 weeks, then 6 weekly until treatment ceases.]