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


Phase 2
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

K. Thomas Robbins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Florida

Authority:

United States: Federal Government

Study ID:

UTENN-6507

NCT ID:

NCT00003580

Start Date:

June 1998

Completion Date:

May 2004

Related Keywords:

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

Name

Location
William F. Bowld Hospital Memphis, Tennessee  38103