Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status

Inclusion criteria

• informed consent signed
• Histological or cytological adenocarcinoma confirmation carcinoma on the esophago-gastric union or stomach (type I, II and III Siervent) metastatic or relapsed
• measurable disease (following RECIST criteria)
• older or equal 70 years old
• Intermediate general status defined as at least one of the following characteristics: performance status (ECOG) = 2, weight loss ponderada between 10 and 25% in the last 3 months
• life expectancy superior to 12 weeks
• adequate hematological function: Neutrophils ≥1.50x109, platelets ≥100x109, Hemoglobin ≥10 g/dl
• adequate liver function: Liver function (total bilirubine < 2 NV; GOT y GPT <3 NV (< 5 NV in case of liver metastasis; Alkaline phosphatase <3 NV ))
• Adequate renal function: renal function (Creatinine clearance > 50mL/min), based on Cockroff - Gault. In case Creatinine clearance is < 50 ml/min, a test in urine will be done in 24 hours and if the value is > 50 ml/min, the patient could be eligible for the study
• Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given
• Use an adequate contraceptive method (postmenopausal women should be amenorrheic at least 12 months previous the study to be considered as not potentially fertile (VN:upper limit on normal laboratory values)

Exclusion criteria

• non measurable lesion as only disease evidence
• previous chemotherapy treatment for advance disease. It wont´t be consider as exclusion criteria if chemo or radiotherapy has been given for localized disease and finished more than 1 year ago. In caso os only measurable disease in the radiated area, progressive disease has to be documented previous to the inclusion
• functional dependency
• hypersensitivity to Docetaxel, oxaliplatin or capecitabine
• previous serious adverse events or unexpected to fluoropirimidin treatment and /or patients with proved deficit in dehidropirimidin deshidrogenase (DPD)
• patients classified as "weak or fragile"

• dependency on one or more of the daily activities following the daily activity scale from Katz
• three or more comorbitities of the following: congestive cardiac insufficiency, cardiac valvulopathy, coronaripathia, chronic pulmonary disease (obstructive or restrictive), cerebrovascular disease, diabetes, concomitant neoplasms, collagen vascular disease, chronic hetopathy and incapacitate arthritis
• presence of geriatric syndromes: moderate-severe dementia, stress delirium (urinary respiratory infection); moderate-severe depression that interfere in the habitual daily life; frequent falls (3 or more monthly); be disattended; urinary incontinence, without stress, infection, diuretics or prostatic hyperplasia; fecal incontinence without diarrhea or laxative; osteoporotic fracture of long bone or vertebral squash
• Cardiac concomitant present:

• Symptomatic auriculoventricular arrhythmia history, and /or
• Congestive cardiac insufficiency non controlled by drugs, and / or
• Myocardial infarct 12 months previous the inclusion, and /or
• Symptomatic ischemic cardiopathy
• active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º, it is required thorax X:ray, hemoculture and urine culture 5 days previous to the inclusion)
• severe or bad controlled concomitant disease
• neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years
• patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment
• not able to fulfill the protocol and follow-up
• being involve in any investigational trial with any drug within 4 weeks prior the study treatment