Treatment of Head & Neck Cancer With Chemotherapy and Radiation
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Bevacizumab; Erlotinib; Paclitaxel; 5-FU; Radiation Therapy
Intervention description: 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; 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; Neoadjuvant: 200 mg/m2 IV, 1-3 hour infusion, Days 1 and 22
Combined Modality: 50 mg/m2 IV, 1 hour IV infusion, weekly x6, beginning day 1 of radiation therapy; Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43; Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
Intervention MeSH terms: Paclitaxel; Bevacizumab; Fluorouracil; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 type of cancer. Treatment will include chemotherapy, radiation therapy and
      targeted therapy taken over a period of 4 months.
    

Eligibility criteria:

        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.