Neoplasm Metastasis, Stomach Neoplasm
Conditions
Keywords
gastric cancer, metastatic, irinotecan
Brief summary
The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary. Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.
Detailed description
Metastatic gastric cancer, progressive disease after one palliative chemotherapy Arm A: Irinotecan 250/350 mg/m2 q3w 1. Cycle:250mg/m2/ 30min 2. Cycle:If no toxicity\>2° CTC, nor Leuko-thrombopenia\>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care
Interventions
DRUGIrinotecan
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median survival | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life, response rates, time to tumor progression, toxicity | — |
Countries
Germany
Outcome results
None listed