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 Treatment Closed physiologic 70 and under NCI UMCC-8327 NCI-T84-0210W, T84-0210

Objectives

I.  Evaluate the antitumor activity of 4'-deoxydoxorubicin in patients with 
unresectable or recurrent non-small cell carcinoma of the lung.
II.  Evaluate the toxicity of 4'-deoxydoxorubicin administered intravenously 
at a dose of 30 mg/sqm every 3 weeks in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed unresectable or recurrent non-small cell carcinoma of the lung, 
including adenocarcinoma, squamous cell carcinoma, and anaplastic large cell 
carcinoma.  Disease must be measurable (i.e., a tumor mass that can be clearly 
measured by physical examination or radiologic methods); pleural effusions are 
not considered measurable unless CT scans demonstrate mass lesions.  Patients 
with malignant hepatomegaly are eligible, provided they have liver enlargement 
at least 5 cm below the costal margin and an abnormal liver scan (scintogram) 
containing one or more clearly defined, measurable defects.  Patients 
previously treated with surgery and/or radiotherapy and previously untreated 
patients are eligible.  There may be no myelosuppressive chemotherapy or 
radiotherapy to major bone marrow-containing areas within 4 weeks of entry, 
and patients must have recovered from the toxic marrow effects of such 
therapy.  Patients with prior anthracycline exposure are ineligible.  A 
Karnofsky performance status of at least 70%, a life expectancy of at least 12 
weeks, and a physiologic age of 70 or less are required.  Patients must have 
adequate bone marrow, liver, and kidney function; there may be no evidence of 
obstructive liver disease.  Clinically acceptable cardiac function (i.e., no 
evidence of CHF or significant arrhythmia) and an AHA classification of I-II 
are required.  There may be no prior or concomitant other malignancy, except 
for surgically cured basal cell carcinoma of the skin or carcinoma in situ of 
the cervix.  Patients with acute intercurrent illnesses (e.g., severe 
infections) and pregnant or lactating females are ineligible.  Females who may 
become pregnant must use effective methods of contraception.  Per March 1984 
addendum, patients previously treated with CBDCA are ineligible.

Expected Enrollment

19 adequately treated patients will be studied initially; if there is at least 
one response among these initial patients, up to 30 patients will be entered.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  4'-Deoxydoxorubicin, DxDx, NSC-267469.

Conley BA, Hornedo J, Abrams J, et al.: Phase II trial of 4'-deoxydoxorubicin in advanced non-small cell lung cancer. Cancer Treat Rep 71(9): 861-862, 1987.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

David Van Echo, MD, Protocol chair(Contact information may not be current)		Ph: 410-328-2665; 800-888-8823 Email: dvanecho@umm.edu