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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over MDA-DM-8523 NCI-V85-0245

Objectives

I.  Determine whether diethyldithiocarbamate prevents or ameliorates cisplatin 
toxicity in patients with recurrent head and neck cancer.
II.  Determine whether diethyldithiocarbamate restores or improves immune 
function in patients with recurrent tumor.
III.  Compare the qualitative and quantitative toxicity of 
cisplatin/5-fluorouracil with and without diethyldithiocarbamate.
IV.  Improve the response rate and duration of survival of patients with 
recurrent head and neck cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 18 or over with 
histologically confirmed squamous cell carcinoma of the head and neck no 
longer amenable to surgery and radiotherapy.  Patients must have received no 
prior chemotherapy (no prior cisplatin and/or 5-fluorouracil, per June 1986 
amendment).  Adequate renal function, adequate bone marrow function, 
measurable or evaluable disease, a life expectancy of at least 12 weeks, and a 
performance status of 2 or better are required.

Expected Enrollment

30 patients will be entered in each group.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  cis-Platinum, Cisplatin, Platinol, 
CDDP, NSC-119875; 5-Fluorouracil, 5-FU, NSC-19893.
Arm II:  2-Drug Combination Chemotherapy plus Supportive Therapy.  CDDP; 5-FU; 
plus Diethyldithiocarbamate, DTC.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Waun Ki Hong, MD, Protocol chair		Ph: 713-794-1441; 800-392-1611 Email: whong@mdanderson.org