Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
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