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Sponsors and Collaborators: |
Gachon University Gil Medical Center Sanofi-Aventis |
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Information provided by: | Gachon University Gil Medical Center |
ClinicalTrials.gov Identifier: | NCT00510107 |
To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.
Condition | Intervention | Phase |
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Stomach Neoplasm Stage IV Recurrent |
Drug: oxaliplatin Drug: Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.
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Drug: Cisplatin
Cisplatin 60 mg/m2 will be given on day 1.
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2: Experimental
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.
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Drug: oxaliplatin
oxaliplatin 120 mg/m2 will be given on day 1.
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Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dong Bok Shin, MD, PhD | 82 32 460 3682 | dbs@gilhospital.com |
Korea, Republic of | |
Gachon University Gil Medical Center | Recruiting |
Incheon, Korea, Republic of, 405 760 |
Principal Investigator: | Se Hoon Park, MD | Gachon University Gil Medical Center, Incheon, Korea |
Study ID Numbers: | GMO-GI-72 |
Study First Received: | July 31, 2007 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00510107 |
Health Authority: | Korea: Food and Drug Administration |
Docetaxel Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin |
Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Recurrence |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |