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Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer

Primary Purpose

Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

amifostine trihydrate

cisplatin

radiation therapy

About this trial

This is an interventional supportive care trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring oral complications, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, drug/agent toxicity by tissue/organ, radiation toxicity

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx Previously untreated Stage III or IV No distant metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 61 mL/min Other: No history of any underlying medical or psychiatric illness Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: No prior therapy for head and neck cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 24 hours since prior antihypertensive medication

Sites / Locations

William F. Bowld Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003580

First Posted

November 1, 1999

Last Updated

June 25, 2013

Sponsor

University of Tennessee

1. Study Identification

Unique Protocol Identification Number

NCT00003580

Brief Title

Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer

Official Title

Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated With Targeted Supradose Cisplatin and Concomitant Radiation Therapy (RADPLAT) in Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

June 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Tennessee

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer.

Detailed Description

OBJECTIVES: I. Determine the efficacy of amifostine in alleviating treatment related mucositis associated with targeted supradose cisplatin and concurrent radiotherapy (RADPLAT protocol) in patients with stage III or IV squamous cell carcinoma of the head and neck. II. Determine the efficacy of amifostine in alleviating other treatment related morbidities associated with this protocol in these patients. OUTLINE: This is an open label, multicenter study of amifostine. Patients receive external beam radiotherapy 5 days a week for approximately 6.5-7.5 weeks. Concurrent with radiotherapy, patients receive amifostine IV over 10 minutes, 30 minutes prior to cisplatin, then cisplatin intra-arterially over 3-5 minutes. Chemotherapy and amifostine course is repeated every week for 4 weeks. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 30 patients will be accrued into this study over 12-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity

Keywords

oral complications, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, drug/agent toxicity by tissue/organ, radiation toxicity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

K. Thomas Robbins, MD

Organizational Affiliation

University of Florida

Official's Role

Study Chair

Facility Information:

Facility Name

William F. Bowld Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer

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