Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00525005
Status:
COMPLETED
Last Update Posted:
2012-09-21
First Post:
2007-09-04
Brief Title:
Docetaxel Oxaliplatin and S-1 DOS for Advanced Gastric Cancer
Sponsor:
Hallym University Medical Center
Organization:
Hallym University Medical Center
Study Overview
Official Title:
A Phase II Study of Docetaxel Oxaliplatin and S-1 DOS in Patients With Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy of combination of docetaxel oxaliplatin and S-1 DOS in the treatment of advanced gastric cancer
Detailed Description:
Docetaxel is an anti-microtubule agent Docetaxel is an active agent for gastric cancer with response rate RR of 20-24 as a single agent and RR of 37-40 as a combination therapy with 5-FU andor cisplatin
S-1 is a new oral dihydropyrimidine dehydrogenase DPD inhibitory fluoropyrimidine DIF In two late phase II studies of S-1 for advanced gastric cancer RR was 45 with very low 2 incidence of grade 3 toxicity
Recent phase III trial of the combination of docetaxel and S-1 in patients with advanced gastric cancer suggests that repeated 3-4 week cycles of S-1 60-80mgm2 day for 14 days combined with docetaxel 40-75mgm2 is feasible
Oxaliplatin diaminocyclohexane-platinum is an alkylating agent inhibiting DNA replication Comparing to cisplatin or carboplatin oxaliplatin appear to be more effective and has a more favorable toxicity profile Phase II studies of the combination of docetaxel and oxaliplatin in patients with advanced gastric cancer suggests that docetaxel 60 or 75mgm2 combined with oxaliplatin 130 or 80mgm2 every 3 weeks is feasible
Recent dose finding study of the combination of docetaxel oxaliplatin and S-1 DOS in patients with advanced gastric cancer suggests that docetaxel 525mgm2 on day 1 and oxaliplatin 105mgm2 on day 1 combined with S-1 80mgm2 on day1 to day 14 every 3 weeks is feasible
Docetaxel S-1 and oxaliplatin have distinct mechanisms of action and no overlapped key toxicities Furthermore fluoropyrimidine and docetaxel or oxaliplatin have shown synergism in vivo studies and in clinical trials Based on these results the combination of DOS is a reasonable candidate of new chemotherapeutic regimen for the advanced gastric cancer
S-1 is a new oral dihydropyrimidine dehydrogenase DPD inhibitory fluoropyrimidine DIF In two late phase II studies of S-1 for advanced gastric cancer RR was 45 with very low 2 incidence of grade 3 toxicity
Recent phase III trial of the combination of docetaxel and S-1 in patients with advanced gastric cancer suggests that repeated 3-4 week cycles of S-1 60-80mgm2 day for 14 days combined with docetaxel 40-75mgm2 is feasible
Oxaliplatin diaminocyclohexane-platinum is an alkylating agent inhibiting DNA replication Comparing to cisplatin or carboplatin oxaliplatin appear to be more effective and has a more favorable toxicity profile Phase II studies of the combination of docetaxel and oxaliplatin in patients with advanced gastric cancer suggests that docetaxel 60 or 75mgm2 combined with oxaliplatin 130 or 80mgm2 every 3 weeks is feasible
Recent dose finding study of the combination of docetaxel oxaliplatin and S-1 DOS in patients with advanced gastric cancer suggests that docetaxel 525mgm2 on day 1 and oxaliplatin 105mgm2 on day 1 combined with S-1 80mgm2 on day1 to day 14 every 3 weeks is feasible
Docetaxel S-1 and oxaliplatin have distinct mechanisms of action and no overlapped key toxicities Furthermore fluoropyrimidine and docetaxel or oxaliplatin have shown synergism in vivo studies and in clinical trials Based on these results the combination of DOS is a reasonable candidate of new chemotherapeutic regimen for the advanced gastric cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None