Status:
COMPLETED
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer
Lead Sponsor:
David M. Brizel, MD
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Head and Neck Cancer
Pharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
Pre Radiation Period: * Bevacizumab (10 mg/kg) on days -14 and 0, or * Tarceva (100 mg) daily from -14-0, or * Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0 Chemoradiat...
Eligibility Criteria
Inclusion
- Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.
- Previous treatment of any sort other than a biopsy is not allowed.
- Eligible anatomic sites:
- oral cavity
- oropharynx
- hypopharynx
- supraglottic
- glottic larynx
- KPS \> 60
Exclusion
- Nasopharynx primary
- History of malignancy other than basal cell skin cancer.
- History of claudication, bleeding, or thromboembolic disorders. Patients receiving heparin or Coumadin therapy are ineligible.
- Primary tumor or lymph node encasement of the carotid artery
- Blood pressure of \>150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein : creatinine ratio ≥ 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- AST, ALT, or bilirubin \> 1.5 x normal
- PT or PTT \> 1.5 x normal
- Platelets \< 100,000
- WBC \< 2000
- Hgb \< 10
- Creatinine clearance \< 60 mL/hr
- Refusal to provide written informed consent
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00140556
Start Date
August 1 2005
End Date
April 1 2010
Last Update
January 18 2013
Active Locations (1)
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1
Department of Radiation Oncology; Duke University Medical Center
Durham, North Carolina, United States, 27710