Irinotecan Versus Only Best Supportive Care for Gastric Cancer

Metastatic gastric cancer, progressive disease after one palliative chemotherapy

Arm A:

Irinotecan 250/350 mg/m2 q3w

• Cycle:250mg/m2/ 30min
• Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care

Inclusion criteria

• Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
• Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
• Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
• Age 18 and 75 years
• Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal limit), ALT und AST < 3x upper normal limit
• Sufficient renal function, defined as serum creatinine < 1,25 x upper normal limit or creatinine clearance >60ml/min calculated according to Crockroft-Gault
• Contraction for patient with reproductive potential
• Karnofsky-Index >60%
• Measurable or evaluable tumor manifestation

Exclusion criteria

• Tumor progression later than 6 months after termination of first-line chemotherapy
• KI 50% or less
• Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
• Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
• Uncontrolled infection
• CNS metastases
• Other severe medical illness
• Prior major surgery less than 2 weeks ago
• Parallel treatment with another experimental therapy
• Parallel treatment with another therapy aiming at tumor reduction
• Chronic diarrhea, subileus
• Chronic inflammatory bowel disease or intestinal obstruction
• Pretreatment with irinotecan