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 no age specified NCI EST-3583 EST-3583

Objectives

I.  Screen new chemotherapeutic agents for activity in patients with advanced 
non-small cell bronchogenic carcinoma.
II.  Randomly compare, in Part B of this protocol, the efficacy and toxicity 
of N-methylformamide vs. spirogermanium vs. 4-demethoxydaunorubicin.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed, measurable or evaluable non-small cell cancer of the lung.  Bone 
marrow, kidney, and liver function must be adequate, and the performance 
status must be 0-2.  There may have been no chemotherapy during the 3 weeks 
prior to entry (6 weeks for nitrosoureas), and patients who have received 
prior anthracycline therapy may not be randomized to the 
4-demethoxydaunorubicin arm.  Patients who have received no prior chemotherapy 
are eligible.  There may have been no prior irradiation of areas of measurable 
or evaluable disease unless progression in these sites has occurred in the 
interim.  Patients may not have received any of the study agents previously.  
Active infections must be controlled prior to entry.  Patients with brain 
metastases are not eligible even if radiotherapy has stabilized these 
metastases.  Per Addendum 2, January 1985, patients who have had a myocardial 
infarction within 6 months, congestive heart failure, or arrhythmia are 
ineligible.  Per Addendum 4, August 1985, patients who were eligible for 
EST-1583, which has been terminated, are now eligible for this study.  Because 
only the 4-demethoxydaunorubicin arm remains open per Addendum 5, October 
1985, patients who have received prior anthracycline therapy are ineligible.

Expected Enrollment

If there is at least one response among the first 14 patients treated on any 
of the treatment arms, accrual in that arm will be continued to a total of 30 
patients.  The estimated required accrual time is one year.  Per Addendum 5, 
Arms I and II have met their accrual goals and entry of patients to these arms 
has been suspended; Arm III remains open to patients who have not previously 
received anthracyclines.

Outline

Randomized study.  Per Addendum 5, October 1985, Arms I and II have met their 
accrual objectives and entry of patients to these arms has been suspended; 
patients who have not received anthracyclines previously will be directly 
assigned to Arm III.
Arm I:  Single-agent Chemotherapy.  N-Methylformamide, N-MF, NSC-3051.
Arm II:  Single-agent Chemotherapy.  Spirogermanium, SPG, NSC-192965.
Arm III:  Single-agent Chemotherapy.  4-Demethoxydaunorubicin.

Ettinger DS, Finkelstein DM, Donehower RC, et al.: Phase II study of N-methylformamide, spirogermanium, and 4-demethoxydaunorubicin in the treatment of non-small cell lung cancer (EST 3583): an Eastern Cooperative Oncology Group study. Med Pediatr Oncol 17 (3): 197-201, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

David Ettinger, MD, Protocol chair		Ph: 410-955-8847 Email: ettinda@jhmi.edu