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Phase II Master Protocol for Single-Agent Chemotherapy for Refractory Small Cell Bronchogenic Carcinoma --- Spirogermanium vs N-Methylformamide

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-4583
EST-4583

Objectives

I.  Screen new agents for antitumor activity in patients with advanced small 
cell bronchogenic carcinoma resistant to treatment with standard agents.
II.  Randomly compare, in this portion of the master protocol, spirogermanium 
vs. N-methylformamide.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed small cell bronchogenic carcinoma, provided there is measurable or 
evaluable disease.  Patients must have failed only one prior chemotherapy 
regimen with standard agents (including combination chemotherapy with CAV or 
CAV-HEM; revised, per Addendum 1, February 1985, to combination chemotherapy 
with CAV, CAVP-16, CAV-HEM, or therapy on protocols EST-1580 or EST-1582) and 
must be at least 3 weeks beyond their last dose of chemotherapy (6 weeks for 
nitrosoureas).  The performance status must be 0-2, and there must be adequate 
functioning of liver, kidney, and bone marrow.  Patients may not have received 
prior treatment with any of the study agents.  Any areas of measurable or 
evaluable disease that have received prior irradiation must have demonstrated 
documented progression in the interim.  Brain metastases exclude.

Expected Enrollment

Thirty patients will be accrued on each treatment arm over an anticipated 
1-year period.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy.  Spirogermanium, SPG, NSC-192965.
Arm II:  Single-agent Chemotherapy.  N-Methylformamide, N-MF, NSC-3051.

Published Results

Ettinger DS, Finkelstein DM, Abeloff MD, et al.: Phase II study of n-methylformamide (NSC 3051) and spirogermanium (NSC 192965) in the treatment of advanced small cell lung cancer. Invest New Drugs 8 (2): 183-5, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Martin Abeloff, MD, Protocol chair(Contact information may not be current)
Ph: 410-955-8822
Email: abeloma@jhmi.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.