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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed over 18 WSU-C-41081

Objectives

I.  Determine the response rate and remission duration of squamous cell 
carcinoma of the head and neck in adult patients treated with aclacinomycin-A 
on a weekly iv schedule.
II.  Define further the qualitative and quantitative toxicities of 
aclacinomycin-A in a Phase II study.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with squamous cell carcinoma 
of the head and neck.  Measurable lesions are required.  Patients must have a 
projected survival of at least 6 weeks and a performance status of at least 3 
(Karnofsky 30-40).  There must be adequate hematologic, renal, and hepatic 
function.  Patients must be off previous chemotherapy or radiotherapy for at 
least 4 weeks prior to protocol entry.  (Prior chemotherapy limited to one 
regimen only per June 1981 addendum.  Cardiac scans are required for patients 
who have failed regimens containing adriamycin or who have received at least 
300 mg/sqm.)  Patients with ischemic heart disease or congestive heart failure 
are ineligible.

Expected Enrollment

14 consecutive chemotherapy-untreated and 14 consecutive chemotherapy-treated 
patients will be entered.  Protocol closed 12/82 with adequate accrual.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Aclacinomycin-A, NSC-208734.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Michael Samson, MD, Protocol chair(Contact information may not be current)		Ph: 313-576-1000 ext. 3327