ACTRN12606000181505CompletedPhase 2
A Phase II study evaluating tumour response of Cetuximab (ErbituxTM) plus weekly docetaxel chemotherapy in docetaxel refractory patients with advanced oesophago-gastric cancer
Australian Gastro-Intestinal Trials Group0 sites35 target enrollmentStarted: May 17, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to ot stated (—)
- Sex
- All
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.
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.
Investigators
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