A randomized phase II study of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. - GATE (GAstric cancer study with Taxotere-Eloxatin-based regimen)

Sanofi-aventis groupe0 sites270 target enrollmentJune 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

June 29, 2006

End Date

April 28, 2010

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Patient’s consent form obtained, signed and dated before beginning specific protocol procedures.
•2\.Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro\-oesophageal junction,
•3\.Metastatic or locally recurrent disease
•4\.Prior adjuvant (and/or neo\-adjuvant) chemotherapy with 5\-FU, CDDP, epirubicin is allowed provided that the patient has relapsed \> 12 months after the end of the chemotherapy.
•5\.At least 4 weeks from prior radiotherapy for palliation of metastases and 3 weeks from surgery.
•6\.Patient age \= 18
•7\.Performance status Karnofsky index \> 70
•8\.Hematology within 7 days before randomization:
•Hb \=10g/dl, ANC \=2\.0 109/L, platelets \=100 x 109/L
•9\.Blood chemistry within 7 days before randomization:

•Patients will be excluded from this study if they meet any of the following criteria:
•1\.Other tumor type than adenocarcinoma
•2\.Any prior palliative chemotherapy.
•3\.Any prior adjuvant (and/or neo\-adjuvant) chemotherapy other than those specified in inclusion criterion \#4\.
•4\.No prior Taxotere® or Eloxatin® or Xeloda®
•5\.Neurosensory symptoms NCI\-CTCAE grade\=2
•6\.Prior radiotherapy other than (neo) adjuvant. In case of (neo)adjuvant radiotherapy, the relapse must be outside the radiotherapy fields
•7\.Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
•8\.Other serious illness or medical conditions:
•\-locally recurrent/metastatic gastric cancer patients often experience intestinal occlusion/stenosis which impair their ability to take oral medications