Randomized Amifostine For SCCHN

January 3, 2017 updated by: Robert I. Haddad, MD, Dana-Farber Cancer Institute

Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.

The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

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
    • Maine
      • Sanford, Maine, United States, 04703
        • Goodall Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Concord, Massachusetts, United States, 01742
        • Bethke Cancer Center at Emerson Hospital
      • Danvers, Massachusetts, United States, 01923
        • Mass General/North Shore Cancer Center
      • Fall River, Massachusetts, United States, 02721
        • Saint Anne's Hospital - Fall River
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Wentworth Douglass Hospital

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

Inclusion Criteria

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
  • Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
  • Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
  • At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
  • No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
  • Age ≥ 18 years.
  • WHO performance status of 0 or 1 (section 13, Appendix I)
  • No active alcohol addiction (as assessed by medical caregiver).
  • Life expectancy ≥ 12 weeks.
  • Signed informed consent prior to beginning protocol specific procedures.

  • Adequate bone marrow, hepatic and renal functions as evidenced by the following:

    • Hematology:

      • neutrophil count ≥ 2.0 x 10 9/1.
      • platelet count ≥ 100 x 10 9/1.
      • hemoglobin ≥ 10 g/dl.

    • Hepatic function:

      • total bilinthin WNL.
      • ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
      • alkaline phosphatase ≤ 5 x ULN.
      • patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
      • x ULN are not eligible for the study.

    • Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:

      • Weight(kg) x (140 - age)/K x serum creatinine

      • serum creatinine in mg/dL

        • K: 72 in man
        • K: 85 in woman

      • serum creatinine in µmon/L

        • K: 0.814 in man
        • K: 0.96 in woman
  • Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers
  • Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
  • Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.

  • Other serious illnesses or medical conditions including but not limited to:

    • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
    • History of significant neurologic or psychiatric disorders including dementia or seizures.
    • Active uncontrolled infection.
    • Active peptic ulcer.
    • Hypercalcemia.
    • Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
  • Patients requiring intravenous alimentation.
  • Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
  • Concurrent treatment with any other anticancer therapy.
  • Participation in an investigational trial within 30 days of study entry.
  • Previous treatment with any biologic therapy is not permitted.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A Amifostine

Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;

  • 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
  • Subcutaneous daily amifostine at a dose of 500 mg
Drug: Carboplatin
Given IV
Other Names:
  • Paraplatin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Onxal
Drug: Amifostine
Given subcutaneously
Other Names:
  • Ethyo
Radiation: radiation
Given once daily for 4 weeks and then twice daily for 2 weeks.
Experimental: Arm B No-Amifostine

Patients with newly diagnosed, locally advanced stage ill or IV SCCHN

- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
Drug: Carboplatin
Given IV
Other Names:
  • Paraplatin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Onxal
Radiation: radiation
Given once daily for 4 weeks and then twice daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of local/regional control (LRC) 1 year after beginning treatment
Time Frame: One year after beginning of treatment
One year after beginning of treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
Time Frame: 3, 6 Months
3, 6 Months
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
Time Frame: End of Radiotherapy
End of Radiotherapy
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
Time Frame: 8,12, 24 and 52 weeks
8,12, 24 and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
Time Frame: 8, 12, 24, and 52 weeks
8, 12, 24, and 52 weeks
Proportion of patients with PEG dependency
Time Frame: 3, 6, and 12 months after completion of study treatment
3, 6, and 12 months after completion of study treatment
Time to disease progression
Time Frame: baseline to disease progression
Kaplan and Meier
baseline to disease progression
Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey
Time Frame: baseline, 8, 12, 24, and 52 weeks after completion of study treatment
baseline, 8, 12, 24, and 52 weeks after completion of study treatment
LRC and overall survival at 2 years after completion of study treatment
Time Frame: 2 Years after completion of study treatment
2 Years after completion of study treatment
Swallowing function
Time Frame: 2 years Post treatment
2 years Post treatment

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
AstraZeneca
MedImmune LLC

Investigators

  • Principal Investigator: Robert I. Haddad, MD, Dana-Farber Cancer Institute

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

May 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (Estimate)

November 9, 2004

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03018
  • P30CA006516 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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