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Phase I/II Study of Amifostine in Combination with Cisplatin, Paclitaxel, and Radiation Therapy in Patients with Locally Advanced, Unresectable Head and Neck Cancer

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

Alternate Title

Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable 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 UIC-H-97-783
ALZA-UIC-H-97-783, NCI-V98-1389, NCT00003251

Objectives

I.   Assess the efficacy and role of amifostine as a cytoprotection agent with 
concurrent chemoradiotherapy in advanced, previously irradiated or metastatic 
head and neck cancer.

II.  Determine the toxicity and response to cisplatin, paclitaxel and 
radiation therapy in these patients.

III. Determine the toxicity of amifostine in these patients.

Entry Criteria

Disease Characteristics:


Histologically or cytologically documented metastatic or previously irradiated
recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head
and neck

Unresectable disease

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified

Chemotherapy:
 At least 1 month since prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 3 months since prior radiotherapy (patients with recurrent disease)
  to head and neck region

Surgery:
 Not speciified

Other:
 At least 24 hours since antihypertensive medication

Patient Characteristics:


Age:
 18 and over

Performance status:
 ECOG 0-2 OR
 Karnofsky 70-100%

Life expectancy:
 Greater than 4 months

Hematopoietic:
 WBC at least 3000/mm3
 Platelet count at least 100,000/mm3
 Granulocyte count at least 1500/mm3

Hepatic:
 Bilirubin no greater than 2.5 times normal
 SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:
 Creatinine no greater than 1.5 mg/dL
 Creatinine clearance at least 60 mL/min

Other:
 No other significant infection
 No other medical or psychiatric illness
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

This study will accrue 16-46 patients.

Outline

This is an open label study.

Patients receive paclitaxel by continuous infusion on days 0-3.  Amifostine IV 
is administered over 5 minutes on days 1-5.  Radiation therapy is administered 
once daily on days 1-5.  Cisplatin IV is administered on day 5.  Patients 
receive no treatment on days 6-13.   Treatment is repeated every 2 weeks for 
up to 7 courses in the absence of disease progression and unacceptable 
toxicity.

Patients are followed monthly during the first year, every 2 months during the 
second year, then every 3 months thereafter.

Trial Contact Information

Trial Lead Organizations

University of Illinois Cancer Center

Fred Rosen, MD, Protocol chair(Contact information may not be current)
Ph: 312-996-7975
Email: frrosen@uic.edu

Registry Information

Official Title		A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer

Trial Start Date		1997-12-01

Registered in ClinicalTrials.gov		NCT00003251

Date Submitted to PDQ		1998-03-05

Information Last Verified		2000-06-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.