Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004865
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2000-03-07
Brief Title:
Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Cetuximab Anti-Epidermal Growth Factor Receptor EGFr Antibody in Combination With Chemotherapy in Patients With Metastatic or Recurrent Squamous Cell Head and Neck Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-03
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 Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating patients who have metastatic or recurrent cancer of the head and neck that has not responded to previous cisplatin-based chemotherapy
PURPOSE Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating patients who have metastatic or recurrent cancer of the head and neck that has not responded to previous cisplatin-based chemotherapy
Detailed Description:
OBJECTIVES I Determine the response rate duration of response and survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with cetuximab and cisplatin after failure of an initial cisplatin-based chemotherapy regimen II Determine the efficacy safety and toxicity of this regimen in these patients III Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study Part I courses 1 and 2 Patients are assigned to 1 of 2 treatment groups based on prior cisplatin-based chemotherapy regimen Group 1 prior cisplatin with paclitaxel Patients receive cisplatin IV over 1 hour on day 1 and fluorouracil IV continuously on days 1-4 Group 2 prior cisplatin with fluorouracil Patients receive cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1 Both groups Treatment repeats every 3 weeks for 2 courses Patients who achieve partial or complete response after completion of course 2 are taken off study Patients with stable disease or disease progression after completion of course 2 proceed to part II of the study Part II courses 3-6 Patients are stratified by response to initial cisplatin-based chemotherapy regimen stable disease vs disease progression Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive cisplatin IV over 1 hour beginning 1 hour after completion of cetuximab infusion on day 1 Patients receive maintenance cetuximab IV over 1 hour on day 8 Maintenance cetuximab repeats weekly Combination treatment repeats every 3 weeks for a maximum of 4 courses Patients with stable or responding disease after completion of course 6 may continue to receive cetuximab alone in the absence of disease progression and at the discretion of the protocol investigator and sponsor Quality of life is assessed before course 1 at the completion of courses 2 4 and 6 and then at 4 weeks after completion of study Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 175 patients will be accrued for this study within 8 months
OUTLINE This is a multicenter study Part I courses 1 and 2 Patients are assigned to 1 of 2 treatment groups based on prior cisplatin-based chemotherapy regimen Group 1 prior cisplatin with paclitaxel Patients receive cisplatin IV over 1 hour on day 1 and fluorouracil IV continuously on days 1-4 Group 2 prior cisplatin with fluorouracil Patients receive cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1 Both groups Treatment repeats every 3 weeks for 2 courses Patients who achieve partial or complete response after completion of course 2 are taken off study Patients with stable disease or disease progression after completion of course 2 proceed to part II of the study Part II courses 3-6 Patients are stratified by response to initial cisplatin-based chemotherapy regimen stable disease vs disease progression Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive cisplatin IV over 1 hour beginning 1 hour after completion of cetuximab infusion on day 1 Patients receive maintenance cetuximab IV over 1 hour on day 8 Maintenance cetuximab repeats weekly Combination treatment repeats every 3 weeks for a maximum of 4 courses Patients with stable or responding disease after completion of course 6 may continue to receive cetuximab alone in the absence of disease progression and at the discretion of the protocol investigator and sponsor Quality of life is assessed before course 1 at the completion of courses 2 4 and 6 and then at 4 weeks after completion of study Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 175 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| NCI-G00-1667 | None | None | None |
| UCLA-9906095 | None | None | None |
| IMCL-CP02-9816 | None | None | None |
| UAB-9917 | None | None | None |