Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301028
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2006-03-08
Brief Title:
Cetuximab Carboplatin and Paclitaxel Followed by Radiation Therapy With or Without Cisplatin in Treating Patients With Metastatic Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Induction Therapy With Cetuximab C225 and CarboplatinPaclitaxel Chemotherapy in Previously Untreated Patients With Advanced Stage IV Head Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-02
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 find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Drugs used in chemotherapy such as carboplatin paclitaxel and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells Giving cetuximab together with combination chemotherapy and radiation therapy with or without cisplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy with or without cisplatin works in treating patients with metastatic head and neck cancer
PURPOSE This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy with or without cisplatin works in treating patients with metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the increase in clinicalradiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab carboplatin and paclitaxel
Determine the toxic effects of this regimen in these patients
Secondary
Determine the pattern of tumor recurrence in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the duration of response time to progression and survival of patients treated with this regimen
Correlate effects of this regimen with biomarkers of response and predictors of long-term outcome in these patients
OUTLINE This is a nonrandomized open-label study
Patients receive induction therapy comprising cetuximab IV over 1-2 hours paclitaxel IV over 1 hour and carboplatin IV over 1 hour on day 1 Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity Beginning 2-3 weeks later patients undergo radiotherapy or chemoradiotherapy Patients with T0 1 2 disease undergo radiotherapy 5 days a week for 6 weeks Patients with T3 4 disease or unresectable nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 Some patients may undergo primary surgical resection before or instead of radiotherapy or chemoradiotherapy
Quality of life is assessed at baseline and at 6 12 and 24 months after completion of radiotherapy or surgery
After study completion patients are followed every 3 months for 2 years every 4 months for 1 year and every 6 months for 2 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Determine the increase in clinicalradiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab carboplatin and paclitaxel
Determine the toxic effects of this regimen in these patients
Secondary
Determine the pattern of tumor recurrence in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the duration of response time to progression and survival of patients treated with this regimen
Correlate effects of this regimen with biomarkers of response and predictors of long-term outcome in these patients
OUTLINE This is a nonrandomized open-label study
Patients receive induction therapy comprising cetuximab IV over 1-2 hours paclitaxel IV over 1 hour and carboplatin IV over 1 hour on day 1 Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity Beginning 2-3 weeks later patients undergo radiotherapy or chemoradiotherapy Patients with T0 1 2 disease undergo radiotherapy 5 days a week for 6 weeks Patients with T3 4 disease or unresectable nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 Some patients may undergo primary surgical resection before or instead of radiotherapy or chemoradiotherapy
Quality of life is assessed at baseline and at 6 12 and 24 months after completion of radiotherapy or surgery
After study completion patients are followed every 3 months for 2 years every 4 months for 1 year and every 6 months for 2 years
PROJECTED ACCRUAL A total of 80 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 |
|---|---|---|---|
| CDR0000441273 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P50CA097007 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-2003-0919 | OTHER | None | None |
| BMS-CA225054 | None | None | None |