Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients

Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic gastric cancer.
* Measurable or evaluable disease.
* Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
* Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
* Karnofsky performance status \> 70%.
* Age ≥18 years.
* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.
* Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

* Active infection
* History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow.
* Patients with CNS metastases
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
* Malnutrition or loss of \> 10% of body weight during the last month.
* Peripheral neuropathy ≥ grade 2
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Psychiatric illness or social situation that would preclude study compliance.
* Pregnant or lactating women.