NCT00144378

Irinotecan Versus Only Best Supportive Care for Gastric Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (planned)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stomach Neoplasm
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Irinotecan

Timeline

• Start date: 2002-10-01
• First posted: 2005-09-05
• Last updated: 2007-04-18

Locations

1 site across 1 country: Germany