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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00144378 |
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.
Condition | Intervention | Phase |
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Stomach Neoplasm Neoplasm Metastasis |
Drug: Irinotecan |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer |
Estimated Enrollment: | 44 |
Study Start Date: | October 2002 |
Metastatic gastric cancer, progressive disease after one palliative chemotherapy
Arm A:
Irinotecan 250/350 mg/m2 q3w
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology, | |
Berlin, Germany |
Principal Investigator: | P Reichardt MD PhD | Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin |
Principal Investigator: | PC Thuss-Patience MD PhD | Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology |
Study ID Numbers: | irinotecan vs. bsc |
Study First Received: | September 2, 2005 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00144378 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
gastric cancer metastatic irinotecan |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Irinotecan Neoplasm Metastasis Gastrointestinal Neoplasms Stomach cancer |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |