Treatment of Head & Neck Cancer With Chemotherapy and Radiation

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00392704
First received: October 25, 2006
Last updated: February 18, 2013
Last verified: February 2013

October 25, 2006
February 18, 2013
December 2006
August 2008   (final data collection date for primary 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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
Feasibility and toxicity of this novel combined modality regimen
Complete list of historical versions of study NCT00392704 on ClinicalTrials.gov Archive Site
Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
Not Provided
Not Provided
Not Provided
 
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

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.

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

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • 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

    Other Name: Avastin
  • 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

    Other Name: Tarceva
  • Drug: Paclitaxel

    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

    Other Name: Taxol
  • Drug: 5-FU
    Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43
    Other Names:
    • 5-fluorouracil
    • Efudex
  • Radiation: Radiation Therapy
    Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
    Other Name: RT
Experimental: Intervention

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.

Interventions:
  • Drug: Bevacizumab
  • Drug: Erlotinib
  • Drug: Paclitaxel
  • Drug: 5-FU
  • Radiation: Radiation Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2012
August 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00392704
SCRI HN 08
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Genentech, Inc.
Principal Investigator: John D Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP