Clinical trial NCT00669370 (phase 2, status: unknown status)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: docetaxel and capecitabine
SMILES: CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O
Eligibility criteria:

        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.