Treatment of Head & Neck Cancer With Chemotherapy and Radiation - Full Text View

Sponsors and Collaborators:	Sarah Cannon Research Institute SCRI Oncology Research Consortium Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00392704

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Bevacizumab Drug: Erlotinib	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Erlotinib hydrochloride Erlotinib Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Feasibility and toxicity of this novel combined modality regimen [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	61
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bevacizumab 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 Drug: 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

Arms

Assigned Interventions

1: Experimental

Drug: Bevacizumab

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

Drug: 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

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 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 MI 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 intraabdominal 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392704

Locations

United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

Sarah Cannon Research Institute

SCRI Oncology Research Consortium

Genentech

Investigators

Principal Investigator:

John D Hainsworth, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	SCRI Oncology Research Consortium ( John D. Hainsworth, M.D. )
Study ID Numbers:	SCRI HN 08, AVF3920s
Study First Received:	October 25, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00392704 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Erlotinib
Paclitaxel
Fluorouracil
Head and Neck Neoplasms
Epidermoid Carcinoma
Carboplatin

Bevacizumab
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Carcinoma

Additional relevant MeSH terms:

Erlotinib
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Bevacizumab
Protein Kinase Inhibitors

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009