Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01588431
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2012-02-29
Brief Title:
BevacizumabPh 2 for Locally Advanced Head and Neck Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Study of Induction Docetaxel Cisplatin Cetuximab and Bevacizumab TPE-A Followed by Concurrent Radiation Cisplatin Cetuximab and Bevacizumab XPE-A in Patients With Locally Advanced Head and Neck Cancer CTRC 11-36
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Locally advanced squamous cell carcinoma of the head and neck SCCHN is treated with various combinations of radiation and chemotherapy This study aims to evaluate the rate of complete responses with induction therapy primary endpoint and progression-free survival overall survival and objective response rates of docetaxel cisplatin cetuximab and bevacizumab TPE-A followed by radiation therapy cisplatin cetuximab and bevacizumab XPE-A Also the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre-and post- treatment tumor biopsies Finally the investigators will evaluate the associated treatment toxicities and the quality of life
Detailed Description:
Locally advanced squamous cell carcinoma of the head and neck SCCHN is treated with various combinations of radiation and chemotherapy Docetaxel and cisplatin have been combined in Phase II trials in recurrent or metastatic head and neck cancer with very encouraging results Induction therapy with docetaxelcisplatin followed by chemoradiotherapy was investigated in a randomized Phase II study in nasopharyngeal cancer and showed superior PFS and OS in comparison with chemoradiation alone Cetuximab is a chimerized EGFR monoclonal antibody that has produced positive results in Phase III trials in combination with either radiation for locally advanced disease or chemotherapy for metastatic disease Upregulation of vascular endothelial growth factor VEGF has been associated with cetuximab resistance Bevacizumab an anti-VEGF antibody is currently being investigated in SCCHN with promising results The investigators have previously shown that cisplatin docetaxel and cetuximab TPE followed by radiotherapy cisplatin and cetuximab XPE is feasible and highly efficacious in locally advanced SCCHN Argiris A et alJCO 2011 In this Phase II study the investigators evaluate the addition of bevacizumab to induction therapy with TPE TPE-A and to subsequent XPE XPE-A
Specific aims
To evaluate the rate of complete responses with induction therapy primary endpoint and progression-free survival overall survival and objective response rates Also the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre- and post- treatment tumor biopsies Finally the investigators will evaluate the associated treatment toxicities and the quality of life
Subject population
The investigators will enroll patients with previously untreated locally advanced SCCHN see detailed eligibility criteria
Treatment plan
Induction therapy consists of 3 cycles of bevacizumab 15mgkg on day 1 docetaxel 75mgm2 on day 1 loading dose of cetuximab 400mgm2 on cycle 1 day 1 then 250 mgm2 on all subsequent administrations Day 8 and 15 of cycle 1 and days 1815 of cycles 2 and 3 cisplatin 75mgm2 on day 1 docetaxel 75mgm2 on day 1 repeated every 21 days After 3 cycles of induction therapy patients will receive standard radiation 70-74 Gy 200 cGy daily 5 days week with concurrent weekly cisplatin 30mgm2 cetuximab 250mgm2 and bevacizumab 15mgkg every 3 weeks x 3 There is optional surgery for non-responders in the primary stable disease after TPE-A
Statistical design and sample size
Phase II two-stage study with complete response rate after induction therapy as the primary endpoint The sample size is 33 patients
Specific aims
To evaluate the rate of complete responses with induction therapy primary endpoint and progression-free survival overall survival and objective response rates Also the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre- and post- treatment tumor biopsies Finally the investigators will evaluate the associated treatment toxicities and the quality of life
Subject population
The investigators will enroll patients with previously untreated locally advanced SCCHN see detailed eligibility criteria
Treatment plan
Induction therapy consists of 3 cycles of bevacizumab 15mgkg on day 1 docetaxel 75mgm2 on day 1 loading dose of cetuximab 400mgm2 on cycle 1 day 1 then 250 mgm2 on all subsequent administrations Day 8 and 15 of cycle 1 and days 1815 of cycles 2 and 3 cisplatin 75mgm2 on day 1 docetaxel 75mgm2 on day 1 repeated every 21 days After 3 cycles of induction therapy patients will receive standard radiation 70-74 Gy 200 cGy daily 5 days week with concurrent weekly cisplatin 30mgm2 cetuximab 250mgm2 and bevacizumab 15mgkg every 3 weeks x 3 There is optional surgery for non-responders in the primary stable disease after TPE-A
Statistical design and sample size
Phase II two-stage study with complete response rate after induction therapy as the primary endpoint The sample size is 33 patients
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 |
|---|---|---|---|
| HSC20120002H | OTHER | UTHSCSA IRB | None |