Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130689
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2005-08-15
Brief Title:
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Purpose There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression induces apoptosis and also inhibits processes important for tumor growth such as cell invasion and angiogenesis
Detailed Description:
OBJECTIVES
Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metastatic setting
Secondary
To evaluate the duration of response progression-free survival and overall survival
To assess the safety of cetuximab
Exploratory
- To assess whether levels of EGFR expression andor EGFR mutation status correlates with response and toxicity of cetuximab
STATISTICAL DESIGN
This study used a two-stage design to evaluate efficacy of cetuximab based on overall response OR defined as complete response CR or partial response PR The null and alternative OR rate were 5 and 15 If one or more patients enrolled in the stage one cohort n20 patients achieved PR or better than accrual would proceed to stage two n16 patients There was 36 probability of stopping the trial at stage one if the true OR rate was 5 The probability that the regimen would be considered promising if the true OR rate was 5 was 10 and 80 if the true OR rate was 15
Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metastatic setting
Secondary
To evaluate the duration of response progression-free survival and overall survival
To assess the safety of cetuximab
Exploratory
- To assess whether levels of EGFR expression andor EGFR mutation status correlates with response and toxicity of cetuximab
STATISTICAL DESIGN
This study used a two-stage design to evaluate efficacy of cetuximab based on overall response OR defined as complete response CR or partial response PR The null and alternative OR rate were 5 and 15 If one or more patients enrolled in the stage one cohort n20 patients achieved PR or better than accrual would proceed to stage two n16 patients There was 36 probability of stopping the trial at stage one if the true OR rate was 5 The probability that the regimen would be considered promising if the true OR rate was 5 was 10 and 80 if the true OR rate was 15
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