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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Closed 18 and over NCI NCI-87-C-18B NCI-T87-0055N, T87-0055

Objectives

I.  Determine whether diethyldithiocarbamate (DDTC) alters the 
pharmacokinetics of cisplatin or carboplatin.
II.  Determine whether DDTC alters the formation of specific DNA-platinum 
adducts in the peripheral white blood cells of patients with ovarian cancer 
receiving treatment with either high-dose cisplatin or high-dose carboplatin.
III.  Determine whether DDTC alters the patterns of toxicity and/or activity 
of high-dose cisplatin and high-dose carboplatin in patients with refractory 
ovarian cancer.
IV.  Evaluate the quality of life and the subjective complaints of peripheral 
neuropathy symptoms over time in patients receiving DDTC with high-dose 
cisplatin or carboplatin.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with epithelial ovarian 
cancer that is refractory to a combination chemotherapy regimen.  Patients may 
not have had prior therapy with more than one cycle of high-dose carboplatin; 
patients who have received prior therapy with high-dose cisplatin are eligible 
if they had an objective response to therapy.

Expected Enrollment

A total of 30 patients (15 per arm) will be treated; the estimated duration of 
the study is 2 years.

Outline

Randomized study (two separate Phase II studies).  Patients who have 
previously received one cycle of high-dose carboplatin will be nonrandomly 
assigned to Arm II.  Patients eligible for either cisplatin plus DDTC or 
carboplatin plus DDTC will be randomized.
Arm I:  Single-agent Chemotherapy plus Toxicity Attenuation.  Cisplatin, 
cis-Platinum, CACP, NSC-119875; plus Diethyldithiocarbamate, DDTC, NSC-038583.
Arm II:  Single-agent Chemotherapy plus Toxicity Attenuation.  Carboplatin, 
CBDCA, NSC-241240; plus DDTC.

Rothenberg ML, Ostchega Y, Steinberg SM, et al.: High-dose carboplatin with diethyldithiocarbamate chemoprotection in treatment of women with relapsed ovarian cancer. J Natl Cancer Inst 80 (18): 1488-92, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Robert Ozols, MD, PhD, Protocol chair		Ph: 215-728-2673; 888-369-2427 Email: robert.ozols@fccc.edu