Treatment of Head & Neck Cancer With Chemotherapy and Radiation
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
1 other identifier
interventional
60
1 country
7
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 type of cancer. Treatment will include chemotherapy, radiation therapy and targeted therapy taken over a period of 4 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 head-and-neck-cancer
Started Dec 2006
Typical duration for phase_2 head-and-neck-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
February 15, 2013
CompletedFebruary 22, 2013
February 1, 2013
1.7 years
October 25, 2006
January 14, 2013
February 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
24 months
Secondary Outcomes (1)
Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
24 Months
Study Arms (1)
Intervention
EXPERIMENTALAll patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22. One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (7)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
Hainsworth JD, Spigel DR, Greco FA, Shipley DL, Peyton J, Rubin M, Stipanov M, Meluch A. Combined modality treatment with chemotherapy, radiation therapy, bevacizumab, and erlotinib in patients with locally advanced squamous carcinoma of the head and neck: a phase II trial of the Sarah Cannon oncology research consortium. Cancer J. 2011 Sep-Oct;17(5):267-72. doi: 10.1097/PPO.0b013e3182329791.
PMID: 21952273BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2006
First Posted
October 26, 2006
Study Start
December 1, 2006
Primary Completion
August 1, 2008
Study Completion
May 1, 2012
Last Updated
February 22, 2013
Results First Posted
February 15, 2013
Record last verified: 2013-02