Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448240
Status:
TERMINATED
Last Update Posted:
2010-02-02
First Post:
2007-03-14
Brief Title:
Erlotinib Tarceva During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Erlotinib Tarceva Given Intermittently During First Line Standard Platinum Containing Chemotherapy for Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual Funding
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 combination Erlotinib CisplatinCarboplatin and Paclitaxel are effective first line treatment for metastatic recurrent and persistent squamous cell carcinoma of the head and neck
Detailed Description:
We hypothesize that Erlotinib fails to enhance the effects of chemotherapy on response and survival because of Erlotinibs cytostatic effect this results in a slowing down of the cell cycle this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination We propose that a sequential approach to the combination allows each drug to be used in its optimum time by sequencing the Erlotinib giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle but delivering the Erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population By withdrawing the Erlotinib about 4 days prior to the next chemotherapy cycle we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again
Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatincarboplatin on Day 1 of each 21 day cycle Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatincarboplatin
The primary objectives of this study are to assess the response rate of combination of erlotinib cisplatincarboplatin and paclitaxel in the first line treatment setting of metastatic recurrent and persistent squamous cell carcinoma of the head and neck Secondary objectives are to assess toxicity median survival and progression free survival
Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatincarboplatin on Day 1 of each 21 day cycle Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatincarboplatin
The primary objectives of this study are to assess the response rate of combination of erlotinib cisplatincarboplatin and paclitaxel in the first line treatment setting of metastatic recurrent and persistent squamous cell carcinoma of the head and neck Secondary objectives are to assess toxicity median survival and progression free survival
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