Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer

Inclusion criteria: * Histologically confirmed advanced, inoperable gastric adenocarcinoma * age ≥18 years * WHO performance status ≤ 2 * Stage IV * Measurable (according to RECIST criteria) or evaluable lesion * No previous chemotherapy, except adjuvant chemotherapy ≥ 6 months ago * Adequate hematological function (neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l, Hb ≥ 100 g/l (after transfusion when needed) * Adequate renal function (serum creatinine ≤ 1.25 x upper normal limit) * Adequate liver function (total serum bilirubin ≤ 1.25 x upper normal limit or ALAT ≤ 3 x upper normal limit; in case of liver metastasis: total serum bilirubin ≤ 1.5 x upper normal limit, ALAT ≤ 5 x upper normal limit) * AFOS ≤ 2.5 x upper normal limit (unless bone metastases) * Consent form signed and dated before inclusion * Able to comply with the scheduled follow-up and with the management of toxicities. Exclusion Criteria: * Pregnant or lactating women (or potentially fertile women not using adequate contraception) * Presence of CNS metastases * Unresolved bowel obstruction or subobstruction * Chronic diarrhea * Clinically significant malabsorption syndrome * Inability to swallow tablets * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within previous 6 months, congestive heart failure * History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin * History of prior serious allergic reactions such as anaphylactic shock. * Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology * Concurrent use of corticosteroids unless chronic treatment (i.e. initiated \> 6 months prior to study entry) at low doses (≥ 20 mg methylprednisolone or equivalent) * History of allergy to drugs containing the excipient TWEEN 80® and/ or 5- fluorouracil. * Lack of physical integrity of the upper gastrointestinal tract. * Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy. * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. * Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.