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 no age specified NCI UMCT-2683 NCI-T83-1308C, T83-1308

Objectives

I.  Assess the clinical antitumor activity and toxicities of N-methylformamide 
administered intravenously, daily for 5 days, every 4 weeks, in patients with 
advanced lung cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically or 
cytologically confirmed, bidimensionally measurable lung cancer, including 
squamous cell, large cell undifferentiated, and small cell undifferentiated 
carcinoma and adenocarcinoma.  Patients may have mixed squamous and 
adenocarcinoma elements, in which case they should be registered as having 
squamous cell carcinoma.  The patient's clinical presentation should be 
compatible with a neoplasm of bronchogenic origin.  Patients with metastatic 
non-small cell lung cancer (NSCLC) Stage IIIM2 are eligible, including 
patients with metastases to the lung or supraclavicular nodes.  All patients 
with small cell lung cancer (SCLC) are eligible if other criteria are met.  
Patients with Stage IIIM0 NSCLC are eligible if they are not better treated by 
radiotherapy.  Patients with NSCLC who are chemotherapy-naive and who are 
eligible for UMCT-1683 must be randomized to receive either UMCT-1683 followed 
by UMCT-2683 or UMCT-2683 followed by UMCT-1683.  NSCLC patients who have 
received one previous chemotherapy trial or who are chemotherapy-naive but 
ineligible for UMCT-1683 may be entered directly into this study without 
randomization.  Patients should be off all prior chemotherapy for at least 3 
weeks prior to entry (6 weeks for nitrosoureas or mitomycin-C) and have 
recovered from all associated toxicities.  Patients with SCLC who have 
progressive disease after standard therapy or after treatment on protocols of 
higher priority (one prior regimen only) should be entered directly into this 
study without randomization.  Patients with prior radiotherapy are eligible if 
the disease has progressed, if at least 6 weeks have elapsed since completion 
of radiotherapy (noncranial), and if measurable sites of disease exist outside 
the previous irradiation field.  Patients with brain metastases receiving 
cranial irradiation are eligible if other measurable sites of disease are 
present outside the brain.  The performance status must be at least 50 percent 
on the Karnofsky scale, and there must be evidence of adequate hepatic, renal, 
and hematopoietic function.  Patients must not have a history of serious 
arrhythmias, myocardial infarction within 6 months, or clinically significant 
(New York Heart Association Grade III/IV) congestive heart failure or angina.

Expected Enrollment

If no response is observed among the first 19 adequately treated NSCLC 
patients (previously treated or chemotherapy-naive), the study will remain 
open to chemotherapy-naive patients only, at least 14 of whom will be 
evaluated.  If there is at least one response among the initial 19 NSCLC 
patients, 25-30 patients will be evaluated.  If at least one response is noted 
among the first 19 previously treated SCLC patients, 25-30 such patients will 
be evaluated; otherwise the study will be closed to previously treated SCLC 
patients.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  N-Methylformamide, N-MF, NSC-3051.

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Ronald Natale, MD, Protocol chair		Ph: 310-423-1101