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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

May 9, 2009

Start Date ^ICMJE

June 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: amifostine trihydrate
Drug: cisplatin
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003580

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066647, UTENN-6507, ALZA-98-066-ii, NCI-V98-1472

Study Sponsor ^ICMJE

UT Bowld Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

K. Thomas Robbins, MD

University of Florida

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2006

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