Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089297
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2004-08-04
Brief Title:
Cetuximab Chemotherapy and Radiation Therapy for Operable Stage III or IV Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Evaluation of Cetuximab C225 Combined With Induction Paclitaxel and Carboplatin Followed by C225 Paclitaxel Carboplatin and Radiation for Stage IIIIV Operable Squamous Cancer 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 block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to damage tumor cells Giving cetuximab with combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving cetuximab after surgery may kill any tumor cells that remain
PURPOSE This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients who are undergoing surgery for stage III or stage IV head and neck cancer
PURPOSE This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients who are undergoing surgery for stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effect of induction therapy comprising cetuximab paclitaxel and carboplatin followed by chemoradiotherapy comprising cetuximab paclitaxel carboplatin and radiotherapy and maintenance therapy comprising cetuximab on 1-year event-free survival freedom from surgery at the primary site and freedom from recurrence and death in patients with stage III or IV operable squamous cell cancer of the head and neck
Secondary
Determine the pathologic antitumor response at the primary site in patients treated with this regimen
Determine disease-free and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine localregional and distant failure rates in patients treated with this regimen
Determine the effect of this treatment regimen on selective biologic pathways total and phosphorylated epidermal growth factor receptor ERKMAPK and P13KAKT in these patients
OUTLINE This is a multicenter study
Induction therapy weeks 1-6 Patients receive cetuximab IV over 1-2 hours paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36
During week 7 or 8 patients undergo biopsy and evaluation of the primary site Patients then proceed to chemoradiotherapy
Chemoradiotherapy weeks 9-13 Patients receive cetuximab IV over 1 hour paclitaxel IV over 1 hour and carboplatin IV over 15 minutes on days 57 64 71 78 and 85 Patients also undergo radiotherapy once daily 5 days a week on weeks 9-13
Patients with a positive biopsy at week 7 or 8 or persistent tumor at the primary site after induction therapy undergo a second biopsy after chemoradiotherapy at week 14 Patients with a negative biopsy at week 7 or 8 who achieve a complete clinical and pathological response at the primary site OR patients whose biopsy becomes negative at week 14 receive an additional 3-weeks of chemoradiotherapy beginning at week 15 Patients receive cetuximab carboplatin and paclitaxel as in chemoradiotherapy as outlined above on days 99 106 and 113 Patients also undergo radiotherapy once daily 5 days a week for 3 weeks weeks 15-17 Patients with N1-N3 disease undergo neck dissection in weeks 20-21
Patients with a positive biopsy at week 14 do not receive additional chemoradiotherapy but rather undergo surgical resection of the primary site in weeks 18-19 Patients with N1-N3 disease also undergo neck dissection at this time
Maintenance therapy Beginning after completion of surgery andor chemoradiotherapy patients receive cetuximab IV over 1 hour once weekly for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
ACTUAL ACCRUAL A total of 74 patients were accrued for this study
Primary
Determine the effect of induction therapy comprising cetuximab paclitaxel and carboplatin followed by chemoradiotherapy comprising cetuximab paclitaxel carboplatin and radiotherapy and maintenance therapy comprising cetuximab on 1-year event-free survival freedom from surgery at the primary site and freedom from recurrence and death in patients with stage III or IV operable squamous cell cancer of the head and neck
Secondary
Determine the pathologic antitumor response at the primary site in patients treated with this regimen
Determine disease-free and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine localregional and distant failure rates in patients treated with this regimen
Determine the effect of this treatment regimen on selective biologic pathways total and phosphorylated epidermal growth factor receptor ERKMAPK and P13KAKT in these patients
OUTLINE This is a multicenter study
Induction therapy weeks 1-6 Patients receive cetuximab IV over 1-2 hours paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36
During week 7 or 8 patients undergo biopsy and evaluation of the primary site Patients then proceed to chemoradiotherapy
Chemoradiotherapy weeks 9-13 Patients receive cetuximab IV over 1 hour paclitaxel IV over 1 hour and carboplatin IV over 15 minutes on days 57 64 71 78 and 85 Patients also undergo radiotherapy once daily 5 days a week on weeks 9-13
Patients with a positive biopsy at week 7 or 8 or persistent tumor at the primary site after induction therapy undergo a second biopsy after chemoradiotherapy at week 14 Patients with a negative biopsy at week 7 or 8 who achieve a complete clinical and pathological response at the primary site OR patients whose biopsy becomes negative at week 14 receive an additional 3-weeks of chemoradiotherapy beginning at week 15 Patients receive cetuximab carboplatin and paclitaxel as in chemoradiotherapy as outlined above on days 99 106 and 113 Patients also undergo radiotherapy once daily 5 days a week for 3 weeks weeks 15-17 Patients with N1-N3 disease undergo neck dissection in weeks 20-21
Patients with a positive biopsy at week 14 do not receive additional chemoradiotherapy but rather undergo surgical resection of the primary site in weeks 18-19 Patients with N1-N3 disease also undergo neck dissection at this time
Maintenance therapy Beginning after completion of surgery andor chemoradiotherapy patients receive cetuximab IV over 1 hour once weekly for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
ACTUAL ACCRUAL A total of 74 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 |
|---|---|---|---|
| E2303 | OTHER | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |