Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer

December 5, 2012 updated by: Philip C. Amrein, M.D., Massachusetts General Hospital

Phase I/II Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer.
  • Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients.
  • Determine the complete response rate and progression-free survival of patients treated with this regimen.
  • Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine.

Patients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses. Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel is given.

Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.

After determination of the MTD for paclitaxel, subsequent patients also receive amifostine IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33. Determination of the MTD for this drug combination is carried out as with paclitaxel alone.

At 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to determine response. Patients with residual masses undergo neck dissection. Patients with complete or partial response at the primary site are followed without surgery.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV squamous cell head and neck cancer

    • T3-4, N0-3, M0

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance Status:

  • ECOG 0-2

Life Expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • Bilirubin no greater than 3.0 mg/dL
  • SGOT no greater than 3 times upper limit of normal

Renal:

  • Creatinine no greater than 3.0 mg/dL

Other:

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent beta-adrenergic blocking agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel, amifostine, RT
Dose-escalation arm for paclitaxel with amifostine and RT.
Radiation: radiation therapy
Drug: amifostine trihydrate
Procedure: conventional surgery
Drug: paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 months
Safety is evaluated in this dose-escalation study
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 6 months
Response in terms of CR, PR, stable disease, or progression was determined
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Percentage of patients alive at 5 years as well as the median overal survival were determined.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Study Chair: Philip C. Amrein, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 22, 2003

First Posted (Estimate)

April 23, 2003

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066028
  • MGH-M7-20
  • ALZA-97-024-ii
  • NCI-V98-1384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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