Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409565
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2006-12-07
Brief Title:
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
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:
The purpose of this study is to determine if the combination of two new drugs cetuximab Erbitux and bevacizumab Avastin can increase the effectiveness of treatment for head and neck cancer Cetuximab has recently been approved by the FDA for head and neck cancer that is locally or regionally advanced when used in combination with radiation therapy Cetuximab is also approved by the FDA for the treatment of colorectal cancer
Detailed Description:
Approximately 40000 new cases of head and neck cancer are diagnosed annually in the United States 1 Squamous cell carcinomas account for more than 90 of head and neck cancer cases Patients with squamous cell carcinoma of the head and neck HNSCC usually present with locoregionally advanced disease Initial presentation with distant metastasis may occur in about 10 of all patients However recurrence of disease either in local or distant sites after potentially curative treatment with surgery radiation andor chemotherapy occurs in more than 50 of patients Therefore the majority of patients with HNSCC develop recurrent or metastatic disease during the course of their illness These patients have a dismal prognosis with a median survival of 6-9 months 2-4
Active single agents in head and neck squamous cell carcinoma include methotrexate bleomycin cisplatin carboplatin 5-FU paclitaxel docetaxel and CPT-11 A small randomized study showed that cisplatin monotherapy prolongs survival compared with best supportive care 5 Response rates for single agents range between 10-40 2 4 6 7 Combination chemotherapy with platinum agents in spite of achieving higher response rates about 30 in phase III trials has not been shown to produce a survival benefit compared to single agents in randomized comparisons in recurrentmetastatic head and neck cancer 2 4
Active single agents in head and neck squamous cell carcinoma include methotrexate bleomycin cisplatin carboplatin 5-FU paclitaxel docetaxel and CPT-11 A small randomized study showed that cisplatin monotherapy prolongs survival compared with best supportive care 5 Response rates for single agents range between 10-40 2 4 6 7 Combination chemotherapy with platinum agents in spite of achieving higher response rates about 30 in phase III trials has not been shown to produce a survival benefit compared to single agents in randomized comparisons in recurrentmetastatic head and neck cancer 2 4
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 CTEP Protocol 7440 | None | None | None |