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.