Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer
Patients with locally advanced or metastatic gastric adenocarcinoma who did not receive any
prior chemotherapy for advanced disease can be enrolled in the study.
Patients are treated with oral capecitabine 1000mg/sqm twice per day on the days 1-14 and
docetaxel 75 mg/sqm on day 1 as a 1 hour i.v. infusion. chemotherapy is repeated every 21
days. Staging by imaging is performed every 2 cycles.
After 40 included patients an amendment was done and the starting of chemotherapy has been
reduced to further improve tolerability. Starting dose of docetaxel was amended to 60
mg/sqm, d1, and starting dose of capecitabine reduced to 800 mg/sqm twice per day, d1-14.
The patient number to be included was increased to 70 pts.
Therapy is continued up to tumor progression to a maximum of 10 cycles. Therapy is stopped
in case of severe side effects, tumor progression or withdrawal of consent.
This investigator initiated study is supported by Hoffmann-La Roche and by Sanofi-Aventis.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
P Reichardt, MD, PhD
Charité, University, Campus-Virchow-Klinikum, Dept. of Hematology and Oncology, Berlin,
Germany: Federal Institute for Drugs and Medical Devices