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Treatment of Head & Neck Cancer With Chemotherapy and Radiation

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Erlotinib
Paclitaxel
5-FU
Radiation Therapy
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Cancer Specialists
  • Watson Clinic Center for Cancer Care and Research
  • Florida Hospital Cancer Institute
  • Center for Cancer and Blood Disorders
  • Grand Rapids Clinical Oncology Program
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

All 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment

Full Information

First Posted
October 25, 2006
Last Updated
February 18, 2013
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00392704
Brief Title
Treatment of Head & Neck Cancer With Chemotherapy and Radiation
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All 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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
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
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
5-fluorouracil, Efudex
Intervention Description
Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT
Intervention Description
Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
Primary Outcome Measure Information:
Title
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
Description
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
Description
The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Watson Clinic Center for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21952273
Citation
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.
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Treatment of Head & Neck Cancer With Chemotherapy and Radiation

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