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 个研究点目标入组 35 人开始时间: 2006年5月17日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

发起方

Australian Gastro-Intestinal Trials Group