Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096174
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2004-11-09
Brief Title:
Phase II Study of Concurrent C225 Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of C225 Erbitux or Cetuximab in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2023-06
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine 2-year progression-free survival in patients with unresectable locally advanced or regional stage IV squamous cell or undifferentiated carcinoma of the head and neck treated with cetuximab cisplatin and definitive radiotherapy
Secondary
Determine response rate and overall survival in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Correlate epidermal growth factor receptor EGFR expression by immunohistochemistry EGFR phosphorylation map kinase Akt signal transducer and activator of transcription 3 STAT3 and other tissue and serum tests with toxicity of this regimen and outcomes in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor site hypopharynx vs oropharynx vs oral cavity vs larynx primary tumor stage T1-3 vs T4 and nodal status N0 vs N1 vs N2-3
Cetuximab therapy Patients receive an initial loading dose of cetuximab IV over 2 hours on day 1 Patients then receive cetuximab IV over 1 hour on days 8 15 22 29 36 43 50 and 57
Chemoradiotherapy Beginning on day 15 of cetuximab therapy patients undergo radiotherapy once daily 5 days a week for at least 7 weeks Patients also receive cisplatin IV over 1-2 hours on days 15 36 and 57
Cetuximab maintenance therapy After the completion of chemoradiotherapy patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 10 years
ACCRUAL A total of 69 patients were accrued for this study
Primary
Determine 2-year progression-free survival in patients with unresectable locally advanced or regional stage IV squamous cell or undifferentiated carcinoma of the head and neck treated with cetuximab cisplatin and definitive radiotherapy
Secondary
Determine response rate and overall survival in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Correlate epidermal growth factor receptor EGFR expression by immunohistochemistry EGFR phosphorylation map kinase Akt signal transducer and activator of transcription 3 STAT3 and other tissue and serum tests with toxicity of this regimen and outcomes in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor site hypopharynx vs oropharynx vs oral cavity vs larynx primary tumor stage T1-3 vs T4 and nodal status N0 vs N1 vs N2-3
Cetuximab therapy Patients receive an initial loading dose of cetuximab IV over 2 hours on day 1 Patients then receive cetuximab IV over 1 hour on days 8 15 22 29 36 43 50 and 57
Chemoradiotherapy Beginning on day 15 of cetuximab therapy patients undergo radiotherapy once daily 5 days a week for at least 7 weeks Patients also receive cisplatin IV over 1-2 hours on days 15 36 and 57
Cetuximab maintenance therapy After the completion of chemoradiotherapy patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 10 years
ACCRUAL A total of 69 patients were accrued for this study
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 |
|---|---|---|---|
| E3303 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |