Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304278
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2006-03-16
Brief Title:
Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma SCCA
Sponsor:
Southern Illinois University
Organization:
Southern Illinois University
Study Overview
Official Title:
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma SCCA
Status:
COMPLETED
Status Verified Date:
2017-06
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:
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva Erlotinib and RADPLAT RADiation and intraarterial cisPLATin for patients with Head and Neck cancer
Detailed Description:
Head and neck malignancies represent a group of epidermoid tumors that arise from the epithelial lining of the mouth pharynx and larynx Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck chemotherapy radiation therapy XRT and surgery The choice of modality depends upon many factors such as the site and extent of the primary lesion the likelihood of complete surgical resection the presence of lymph node metastases etc Traditionally smaller lesions stage T1-T2 are effectively treated either by surgical excision or irradiation whereas more advanced disease stage III-IV is treated with combined surgery and XRT The subsequent morbidity related to extensive surgery is a major problem among survivors Clearly there is a need to develop therapeutic strategies for patients with advanced head and neck cancer with more effective approaches employing non-surgical modalities
Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage induced by radiation and chemotherapy This resistance is mediated by EGFR overexpression which results in downstream activation of cell survival signals such as AKT and may be overcome when Erlotinib Tarceva is co-administered with RADiation and cisPLATin intraarterial chemotherapy
Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage induced by radiation and chemotherapy This resistance is mediated by EGFR overexpression which results in downstream activation of cell survival signals such as AKT and may be overcome when Erlotinib Tarceva is co-administered with RADiation and cisPLATin intraarterial chemotherapy
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 |
|---|---|---|---|
| Genentech Inc | None | None | None |