| Inclusion Criteria: | 1) Histologically documented adenocarcinoma of the stomach or GEJ.
2) Age >18 years;
3) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
4) Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a radiosensitization is permitted, provided that the minimum time from completion of such treatment to study entry is at least 12 months;
5) Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 14 days must have elapsed since the end of radiotherapy.
6) Previous Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration. Minimum of 14 days must have elapsed between a major surgery and start of chemotherapy.
7) At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions are in a previously irradiated field, only a clear disease progression of the irradiated lesion or a new lesion in the previously irradiated field will be accepted
8) Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils >1.5 x 10*9/L and platelets >100 x 10*9/L; Bilirubin <1.5 x upper limit of the normal range (ULN); AST and/or ALT <2.5 x ULN; Serum creatinine <1.5 x ULN;
9) Patients must give written informed consent to participate in the study.
10) Patients – both males and females – with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to registration. |