A Phase II Trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed By Concurrent Chemotherapy/Bevacizumab/Erlotinib/Radiation Therapy in the Treatment of Locally Advanced Squamous Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed By Concurrent Chemotherapy/Bevacizumab/Erlotinib/Radiation Therapy in the Treatment of Locally Advanced Squamous Carcinoma of the Head and Neck
In this trial, patients will receive induction treatment with combination
chemotherapy(paclitaxel/carboplatin/infusional 5FU) plus bevacizumab. After 6 weeks of
treatment, patients will be reevaluated and will then receive concurrent radiation therapy,
chemotherapy (weekly paclitaxel),bevacizumab, and erlotinib.
Induction Treatment:
Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein
over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22
5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
Combined Modality Treatment:
Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib
150mg by mouth daily during the entire course of radiation (approximately 7 weeks)
Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation
therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of
radiation therapy
Inclusion Criteria:
- Clinically confirmed head & neck cancer
- Considered low cure rate with local therapy
- No prior treatment for this cancer
- Able to be up & about and perform self care
- Adequate renal and liver function
- Must be 18 years of age or older
- All patients will need an indwelling central venous access catheter
- Must be able to give written informed consent
Exclusion Criteria:
- Active cancer treatment in the last 5 years
- Pregnant or lactating women
- History of stroke, transient ischemic attacks, or acute myocardial infarction within
the past 6 months or any other serious cardiovascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess
within 6 months
- History of uncontrolled hypertension
- Symptomatic peripheral vascular disease
Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to
participate.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment
Outcome Description:
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
John D Hainsworth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Institutional Review Board
Study ID:
SCRI HN 08
NCT ID:
NCT00392704
Start Date:
December 2006
Completion Date:
May 2012
Related Keywords:
- Head and Neck Cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |
| Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
