We therefore evaluated two novel regimens based selleck chemicals llc on weekly docetaxel in a randomised phase II design called the ATTAX study (A randomised phase Two study evaluating a weekly schedule of doceTAXel with cisplatin and 5-FU (weekly TCF, wTCF) or with capecitabine (weekly TX, wTX) in advanced oesophagogastric cancer). Patients and methods Eligibility The ATTAX study was conducted according to a protocol reviewed and approved by the Australasian Gastro-Intestinal Trials Group (AGITG), and reviewed and approved by the Human Research Ethics Committee of each participating institution. All patients provided written informed consent.

Patients were eligible if they were 18 years of age or older with a histologically confirmed diagnosis of oesophageal, gastric, or oesophagogastric junction carcinoma (squamous, adenocarcinoma or undifferentiated), and of metastatic disease that was unidimensionally measurable according to the Response Evaluation Criteria in Solid Tumours (RECIST). Inclusion of oesophageal, oesophagogastric, and gastric cancers is justified by data showing comparable outcomes for these diseases (Chau et al, 2009a). Similarly, outcomes for patients with advanced squamous cell carcinoma are not significantly different from those for patients with adenocarcinoma (Chau et al, 2007). Patients were not allowed to have had previous anticancer treatment, except for adjuvant radiotherapy or chemotherapy completed at least 12 months before. Further inclusion criteria included WHO performance status (PS) of 0, 1, or 2 (PS2 patients were required to have serum albumin of at least 30gl?1); adequate bone marrow function, including platelets (>100 �� 109 cells per l) and neutrophils (>1.

5 �� 109 cells per l); normal renal function, including normal serum creatinine and calculated creatinine clearance of at least 50mlmin?1; and adequate hepatic function, including serum total Dacomitinib bilirubin <1.25 �� upper limit of normal range, alanine transaminase or aspartate transaminase <2.5 �� upper limit of normal range, and alkaline phosphatase <5 �� upper limit of normal range. In addition, patients had to be able to swallow tablets, have a life expectancy of more than 12 weeks, and have no concurrent uncontrolled medical conditions and no previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix or other cancers treated with curative intent at least 5 years previously and without evidence of relapse. Patients were required to have a negative pregnancy test and had to agree to practise adequate contraception.