Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	18 and over	Pharmaceutical / Industry	MGH-M7-20 ALZA-97-024-ii, NCI-V98-1384, NCT00003193

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage III or IV squamous cell head and neck cancer
  • T3-4, N0-3, M0

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

Patient Characteristics:

Age:

• 18 and over

Performance Status:

• ECOG 0-2

Life Expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm³
• Platelet count at least 50,000/mm³

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

Expected Enrollment

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

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.

Amrein PC, Clark JR, Supko JG, et al.: Phase I trial and pharmacokinetics of escalating doses of paclitaxel and concurrent hyperfractionated radiotherapy with or without amifostine in patients with advanced head and neck carcinoma. Cancer 104 (7): 1418-27, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Massachusetts General Hospital

Philip Amrein, MD, Protocol chair		Ph: 617-726-8748; 877-726-5130 Email: pamrein@partners.org

Registry Information
Official Title		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
Trial Start Date		1998-01-09
Registered in ClinicalTrials.gov		NCT00003193
Date Submitted to PDQ		1998-01-22
Information Last Verified		2003-03-19

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