Status:
COMPLETED
Treatment of Head & Neck Cancer With Chemotherapy and Radiation
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this ty...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00392704
Start Date
December 1 2006
End Date
May 1 2012
Last Update
February 22 2013
Active Locations (7)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
3
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
4
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817