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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed 18 and over WCCC-CO-8751 NCI-V87-0225

Objectives

I.  Determine the response rate and survival of patients with inoperable 
non-small cell lung cancer treated for 6 weeks with recombinant beta-serine 
interferon/recombinant gamma interferon (IFN-beta-ser/IFN-gamma) followed by 
two courses of chemotherapy with etoposide/cisplatin (VP-16/DDP).
II.  Compare the response rate and survival of patients treated on the regimen 
above to that of patients treated with VP-16/DDP alone provided the regimen 
above produces results that warrant continuation of the study.
III.  Determine whether reinduction with IFN-beta-ser/IFN-gamma followed by 
VP-16/DDP can reinduce disease regression in patients who had initial 
responses to therapy but subsequently developed progressive or recurrent 
disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 and older with 
inoperable, histologically confirmed non-small cell bronchogenic carcinoma 
(adenocarcinoma).  Sputum cytology alone is not acceptable evidence of cell 
type; cytologic specimens obtained by brushing, washing, or needle aspiration 
of a defined lesion are acceptable.  Mixed tumors are categorized by the 
predominant cell type unless small cell anaplastic elements are present, in 
which case the patient is ineligible; patients with small cell carcinoma are 
excluded.  Prior chemotherapy or therapy with interferon or other 
immunomodulatory agents excludes; neither radiotherapy nor glucocorticosteroid 
use is permitted within 2 weeks of study treatment, and patients must have 
recovered from the side effects of previous irradiation.  Concurrent 
palliative chemotherapy, radiotherapy, hormonal therapy, or immunotherapy is 
prohibited; patients may not be given barbiturates (unless on a constant daily 
dose for more than 1 month prior to study), nonsteroidal or steroidal 
anti-inflammatory agents, or aspirin while on study.  Patients must not have 
had a serious infection (e.g., pneumonia) or major surgery within the 14 days 
prior to study entry.  Bidimensionally measurable disease is required, as 
demonstrated by x-ray (including computer and routine tomography) or physical 
examination; hepatomegaly can be employed as a measurable lesion if the liver 
has been proven to contain metastases and if a clearly palpable liver edge 
extends at least 5 cm below the xiphoid process or costal margins on quiet 
respiration.  Bone and liver scans are not acceptable as the sole measures of 
disease; a single site of measurable disease may not be within the portal of 
previous irradiation unless there is documentation of disease progression (at 
least a 25% increase) in the interim.  Patients must have an ECOG performance 
status of 0 or 1, WBC and platelets at least 4,000/cumm and 100,000/cumm, 
respectively, bilirubin no greater than 2.0 mg%, SGOT no greater than twice 
the upper limit of normal, BUN no greater than 25 mg% and creatinine no 
greater than 1.5 mg%.  Patients with NY Heart Association class III or IV 
heart disease, heart disease requiring therapy with anti-arrhythmic drugs such 
as procainamide, quinidine, or disopyramide (digitalis preparation are 
permitted), angina pectoris requiring medication, or myocardial infarction 
within the previous 6 months are not eligible; a significant history of 
hypersensitivity to penicillin or penicillin analogs excludes.  Patients with 
brain metastases are ineligible even if metastases have been stabilized by 
irradiation; there may be no prior uncontrolled malignancies except skin 
cancer, but patients whose prior malignancies have been controlled for more 
than 5 years may be eligible pending confirmation and discussion with the 
study chairman.  Patients with a history of depression should be followed 
closely while receiving interferon; those whose medical or psychiatric risks 
would compromise their ability to give informed consent or complete the study 
may not participate.  Pregnancy or lactation excludes; women of childbearing 
potential must take precautions to prevent pregnancy during treatment.

Expected Enrollment

14 patients will be randomized to Arm I, at least 9 of whom will have a 
histology of adenocarcinoma.  If at least 5 of the 14 patients studied 
respond, 46 patients will be randomized to each arm for a study total of 92 
patients.

Outline

Randomized study.
Arm I:   Combined Interferon Therapy followed by 2-Drug Combination 
Chemotherapy.  Human Recombinant Beta-Serine Interferon (Cetus), IFN-beta-ser, 
NSC-373361; Human Recombinant Gamma Interferon (Biogen), IFN-gamma, 
NSC-373360; followed by Cisplatin, DDP, NSC-119875; Etoposide, VP-16, 
NSC-141540.
Arm II:  2-Drug Combination Chemotherapy.  DDP; VP-16.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Ernest Borden, MD, Protocol chair		Ph: 216-444-8183; 800-862-7798 Email: bordene@ccf.org