Status:
COMPLETED
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Stomach Neoplasm
Neoplasm Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00144378
Start Date
October 1 2002
Last Update
April 18 2007
Active Locations (1)
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1
Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
Berlin, Germany