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Sponsored by: |
Samsung Medical Center |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00533533 |
Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1 year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as 5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4 months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective response rate of 50%, which included a 4% complete response. The preclinical studies, oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines, thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied previously in the phase I setting in patients with metastatic breast and non-small cell lung cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated regimen.
Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on day 2 without G-CSF support.
The aim of this trial is to determine the dose limiting toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as combination chemotherapy in patients with advanced gastric cancer.
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: docetaxel, oxaliplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer |
Estimated Enrollment: | 68 |
Study Start Date: | January 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Oxaliplatin will be administered in combination with docetaxel as a first-line chemotherapy in advanced gastric cancer patients. Each cycle is repeated every 3 weeks.
Docetaxel Oxaliplatin Level 1 60 mg/m2/day 1 100 mg/m2/day 1 Level 2 75 mg/m2/day 1 100 mg/m2/day 1 Level 3 75 mg/m2/day 1 130 mg/m2/day 1
Primary objectives :
To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study
Secondary objectives :
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Young Suk Park, M.D., Ph.D. | Samsung Medical Center, Seoul, KOREA |
Responsible Party: | Samsung Medical Center ( Young Suk Park ) |
Study ID Numbers: | 2005-10-047 |
Study First Received: | September 19, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00533533 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Docetaxel,Oxaliplatin Phase I/II study Advanced gastric cancer First line treatment Advanced gastric cancer with measurable disease |
Docetaxel Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer |
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Pharmacologic Actions Docetaxel Neoplasms Oxaliplatin |
Neoplasms by Site Digestive System Diseases Stomach Diseases Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms |