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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 InstituteOrlando, Florida  32804
Florida Cancer SpecialistsFort Myers, Florida  33901
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Watson Clinic Center for Cancer Care and ResearchLakeland, Florida  33805
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404