Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140556
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2005-08-29
Brief Title:
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer
Sponsor:
David M Brizel MD
Organization:
Duke University
Study Overview
Official Title:
Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Radiotherapy RT with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck Tumor hypoxia and high levels of angiogenesis blood vessel formation are associated with treatment failure Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor VEGF Curability may consequently be reduced by multiple mechanisms Over-expression of epidermal growth factor receptor EGFR also occurs commonly and increases the risk of treatment failure The addition of EGFR blockade to RT alone increases the chance of a cure Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer
This study will add angiogenic and epidermal growth factor receptor EGFR blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin CDDP chemotherapy will be determined
This study will add angiogenic and epidermal growth factor receptor EGFR blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin CDDP chemotherapy will be determined
Detailed Description:
Pre Radiation Period
Bevacizumab 10 mgkg on days -14 and 0 or
Tarceva 100 mg daily from -14-0 or
Bevacizumab 10 mgkg on days -14 and 0 Tarceva 100 mg daily from -14-0
Chemoradiation Period
Radiotherapy may be delivered via conventional 2-D conformal 3-D or intensity modulated IMRT technique as is clinically indicated Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts
RT 125 Gy BID M-F with a 6 hour interfraction interval
Treatment break during week 4 Total dose 70 Gy7 weeks
CDDP 33 mgm2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens
Bevacizumab 10mgkg Monday of weeks 1 3 5 7 of RT
Tarceva 100 mg Daily for weeks 1-7 of treatment except for days receiving CDDP
Safety Assessments
Baseline and then weekly assessments of blood pressure and urine protein creatinine ratios during lead in and chemoRT phases of treatment
Baseline carotid Doppler ultrasound evaluation
Carotid Doppler ultrasound evaluation 1 month post-chemoRT
Efficacy Assessments
MR ImagingSpectroscopy to be done at baseline end of lead-in phase end of week 1 of chemoRT and end of chemoRT
Angiogenic and EGFR related cytokines Specifically blood samples will be obtained to assay levels of VEGF b-FGF IL-8 D-dimer EGF TGF These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment day -7
Clinical Assessments
All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopylaryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer
Patient compliance with Tarceva administration monitored via diary MRIMRS Magnetic Resonance Spectroscopy DE-MRI
Bevacizumab 10 mgkg on days -14 and 0 or
Tarceva 100 mg daily from -14-0 or
Bevacizumab 10 mgkg on days -14 and 0 Tarceva 100 mg daily from -14-0
Chemoradiation Period
Radiotherapy may be delivered via conventional 2-D conformal 3-D or intensity modulated IMRT technique as is clinically indicated Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts
RT 125 Gy BID M-F with a 6 hour interfraction interval
Treatment break during week 4 Total dose 70 Gy7 weeks
CDDP 33 mgm2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens
Bevacizumab 10mgkg Monday of weeks 1 3 5 7 of RT
Tarceva 100 mg Daily for weeks 1-7 of treatment except for days receiving CDDP
Safety Assessments
Baseline and then weekly assessments of blood pressure and urine protein creatinine ratios during lead in and chemoRT phases of treatment
Baseline carotid Doppler ultrasound evaluation
Carotid Doppler ultrasound evaluation 1 month post-chemoRT
Efficacy Assessments
MR ImagingSpectroscopy to be done at baseline end of lead-in phase end of week 1 of chemoRT and end of chemoRT
Angiogenic and EGFR related cytokines Specifically blood samples will be obtained to assay levels of VEGF b-FGF IL-8 D-dimer EGF TGF These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment day -7
Clinical Assessments
All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopylaryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer
Patient compliance with Tarceva administration monitored via diary MRIMRS Magnetic Resonance Spectroscopy DE-MRI
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 |
|---|---|---|---|
| 7077 | OTHER | Legacy IRB number | None |