Clinical trial NCT00511446 (phase 2, status: completed)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: docetaxel, oxaliplatin, capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Histologically proven irresectable, metastatic or recurrent adenocarcinoma of the
             stomach or the gastroesophageal junction, i.e., Tx-4 M1 or T4 M0

          -  Irresectable (as judged by an experienced surgeon):

               1. T4 infiltrating of several organs

               2. T4 infiltrating one organ, but irresectable

               3. T4 infiltrating one organ, respectable, but inoperable patient

          -  The nodal status is neglected

          -  Measurable disease according to RECIST

          -  ECOG Performance Status ≤ 2

          -  Male or female patients aged ≥ 18 years

          -  Life expectancy ≥ 3 months

          -  Adequate bone marrow, hepatic and renal function:

               1. Haemoglobin > 9.0 g/dL (transfusions allowed to achieve or maintain levels)

               2. Absolute neutrophil count > 1.5 x 10^9/L

               3. Platelet count > 100 x 10^9/L

               4. ALAT, ASAT < 3.5 x ULN

               5. Alkaline phosphatase < 6 x ULN

               6. Total bilirubin < 1.0 x ULN

               7. Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)

          -  Prior surgery must be more than 28 days ago

          -  Positive nodes as diagnosed on endorectal ultrasound and/or MRI (tumour is staged by
             preferably a high resolution MRI; if MRI is not available, locoregional staging must
             be performed by computed tomography plus endorectal ultrasound)

          -  Tumor staging must be done within 28 days from the start of the treatment

          -  Negative pregnancy test in women with childbearing of potential (within 7 days prior
             to the start of the chemotherapy)

               -  Postmenopausal women must have been amenorrheic for at least 12 months to be
                  considered of non-childbearing potential

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy or radiotherapy (a neoadjuvant or adjuvant chemotherapy
             must be completed and without progression for at least 6 months)

          -  Previous (within the last 5 years) or concurrent malignancies, with the exception of
             adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin

          -  Peripheral neuropathy ≥ grade 2 (according to NCI CTCAE v 3.0)

          -  Patient must not have been treated with any investigational drug, agent nor procedure,
             (i.e., did not participate in another trial within 30 days) before entry in this trial

          -  Known allergy or any other adverse reaction to any of the study drugs or to any
             related compound

          -  Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
             chemically related analogues, such as brivudine

          -  Clinically significant concomitant diseases, such as:

               1. Active infection necessitating systemic antibiotics

               2. Interstitial lung diseases

               3. Chronic diarrhea, inflammatory bowel disease

               4. Neurological or psychiatric disease, dementia, epilepsy or untreated brain
                  metastases

          -  Cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease
             and cardiac arrhythmia not well controlled with medication) or myocardial infarction
             or resuscitation within the last 6 months

          -  Pregnant or lactating women are excluded

          -  Presence of adequate contraception in fertile patients (methods of adequate
             contraception are: intra-uterine device, hormonal contraception, vasectomy, tubal
             ligation or abstinence)

          -  Alcohol or drug abuse

          -  Ability to swallow tablets

          -  Psychological, familial, sociological or geographical condition potentially hampering
             compliance with the study protocol and follow-up schedule