Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517829
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2007-08-15
Brief Title:
DocetaxelOxali-Cetux Met GastricGEJ
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
Phase II Trial of Docetaxel Plus Oxaliplatin DOCOX With or Without Cetuximab in Patients With Metastatic Gastric andor Gastroesophageal Junction Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-10
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 research study is to find out what effects good and bad docetaxel oxaliplatin and cetuximab have on gastric or GEJ cancer
Detailed Description:
This is a Phase II open- label randomized noncomparative study Patients will be stratified at randomization by ECOG PS There is no intent to have equal numbers of patients for each PS ie 0 1 and 2 but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS
Patients will be randomly assigned to either Arm 1 - Taxotere 60 mgm2 as an intravenous IV infusion over 1 hour followed by Eloxatin 130 mgm2 IV over 2 hours or Arm 2 - Taxotere 60 mgm2 as an IV infusion over 1 ho ur followed by Eloxatin 130mgm2 IV over 2 hours followed by ERBITUX 400 mgm2 IV over 120 minutes first dose only all other doses are 250 mgm2 over 60 minutes Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle ERBITUX is given on Days 1 8 and 15 of each cycle
Treatment will continue until disease progression or intolerable toxicity Patients who achieve a CR will receive an additional 2 cycles of treatment Patients will be limited to 24 months of participation counted from the date of the first dose of study drug
Patients will be randomly assigned to either Arm 1 - Taxotere 60 mgm2 as an intravenous IV infusion over 1 hour followed by Eloxatin 130 mgm2 IV over 2 hours or Arm 2 - Taxotere 60 mgm2 as an IV infusion over 1 ho ur followed by Eloxatin 130mgm2 IV over 2 hours followed by ERBITUX 400 mgm2 IV over 120 minutes first dose only all other doses are 250 mgm2 over 60 minutes Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle ERBITUX is given on Days 1 8 and 15 of each cycle
Treatment will continue until disease progression or intolerable toxicity Patients who achieve a CR will receive an additional 2 cycles of treatment Patients will be limited to 24 months of participation counted from the date of the first dose of study drug
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