Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	UAB-154 NCI-T83-1229D, T83-1229

Objectives

I.  Determine the maximum tolerated dose (MTD) of cis-platinum given by 
short-term intra-arterial infusion through the side port of the Infusaid Pump.
II.  Determine the MTD of dichloromethotrexate given by continuous 
intra-arterial infusion in combination with cis-platinum.
III.  Determine the objective response rate and duration of response produced 
by cis-platinum/dichloromethotrexate in patients with advanced head and neck 
cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven, 
measurable squamous cell carcinoma primary in the head and neck who are not 
candidates for curative therapy with surgery or irradiation.  Detectable tumor 
must be confined to the head and neck without distant metastases.  The blood 
supply of the entire tumor volume must be derived from one external carotid 
artery and/or the thyrocervical trunk or both external carotid arteries.  
Patients must have objective evidence of disease progression following any 
prior therapy; those patients who received prior systemic therapy with 
methotrexate or cis-platinum are eligible but will be analyzed separately.  
Life expectancy must be at least 8 weeks, and the Karnofsky performance status 
must be at least 60.  Patients over the age of 70 must have a Karnofsky 
performance status of at least 80 and must have no clinical evidence of CNS 
vascular disease.  WBC and platelet counts must be at least 3,500/cumm and 
150,000/cumm, respectively; liver and kidney function must be adequate.  
Patients must be candidates for general anesthesia for catheter implantation, 
and cardiac status must be adequate for receiving vigorous hydration (i.e., no 
congestive heart failure or recent myocardial infarction).

Expected Enrollment

The Phase I component of the study will be completed when 50% or more of the 
patients at the highest CACP dose achieve the MTD.

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy.  cis-Platinum, CACP, NSC-119875; 
Dichloromethotrexate, DCM, NSC-29630.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Richard Wheeler, MD, Protocol chair(Contact information may not be current)		Ph: 801-585-0303; 877-585-0303