Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005814
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-06-02
Brief Title:
Cetuximab Cisplatin and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of C225 in Combination With Cisplatin and StandardDelayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head Neck Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 use 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 Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cetuximab cisplatin and radiation therapy in treating patients who have advanced stage III or stage IV head and neck cancer
PURPOSE Phase II trial to study the effectiveness of combining cetuximab cisplatin and radiation therapy in treating patients who have advanced stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES I Determine the response rate in patients with newly diagnosed or recurrent advanced stage III or IV squamous cell carcinoma of the head and neck treated with 6 infusions of cetuximab at loadingmaintenance doses in combination with 2 infusions of cisplatin concurrent with standarddelayed accelerated hyperfractionated radiotherapy followed by 4 weeks of single agent cetuximab II Assess the safety profile of this treatment regimen in this patient population III Evaluate time to disease progression and survival in these patients treated with this regimen IV Assess the impact of this treatment regimen on the quality of life of these patients
OUTLINE Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed by 5 weekly maintenance doses over 60 minutes on weeks 2-6 Patients receive cisplatin IV over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and 6 Following the initial 6 weeks of treatment patients receive additional cetuximab IV over 30 minutes weekly on weeks 7-10 Quality of life is assessed at baseline within 4 weeks after completion of all treatment and at 3-4 months Patients are followed at 4-6 weeks 12-16 weeks every 3 months for 2 years every 4 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
OUTLINE Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed by 5 weekly maintenance doses over 60 minutes on weeks 2-6 Patients receive cisplatin IV over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and 6 Following the initial 6 weeks of treatment patients receive additional cetuximab IV over 30 minutes weekly on weeks 7-10 Quality of life is assessed at baseline within 4 weeks after completion of all treatment and at 3-4 months Patients are followed at 4-6 weeks 12-16 weeks every 3 months for 2 years every 4 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A maximum of 25 patients will be 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 |
|---|---|---|---|
| NCI-G00-1785 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067817 | REGISTRY | None | None |