Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer (GAST-TaxXel)

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.