Spots Global Cancer Trial Database for Irinotecan Versus Only Best Supportive Care for Gastric Cancer

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Trial Identification

Brief Title: Irinotecan Versus Only Best Supportive Care for Gastric Cancer

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

Study ID: NCT00144378

Conditions

Stomach Neoplasm

Neoplasm Metastasis

Interventions

Irinotecan

Study Description

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