Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 5:32 PM
Study NCT ID:
NCT00533533
Status:
COMPLETED
Last Update Posted:
2009-01-14
First Post:
2007-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2006-11
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:
DO for AGC
Brief Summary:
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.
Detailed Description:
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 :
1. To evaluate the safety and tolerability of the treatment combination.
2. To estimate overall survival.
3. To estimate the time to progression and the duration of overall response.
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 :
1. To evaluate the safety and tolerability of the treatment combination.
2. To estimate overall survival.
3. To estimate the time to progression and the duration of overall response.
Study Oversight
Has Oversight DMC:
True
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?: