Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096031
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2004-11-09
Brief Title:
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
Status:
COMPLETED
Status Verified Date:
2018-08
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:
RATIONALE Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer
PURPOSE This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy
Determine the response rate confirmed and unconfirmed complete and partial time to progression and time to treatment failure in patients treated with this drug
Determine the toxicity of this drug in these patients
Correlate preliminarily gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway DNA repair and angiogenesis with time to progression response overall survival toxic effects and time to treatment failure in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours on day 1 Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study within 6-14 months
Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy
Determine the response rate confirmed and unconfirmed complete and partial time to progression and time to treatment failure in patients treated with this drug
Determine the toxicity of this drug in these patients
Correlate preliminarily gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway DNA repair and angiogenesis with time to progression response overall survival toxic effects and time to treatment failure in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours on day 1 Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study within 6-14 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0415 | OTHER | None | None |