Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed any age NCI EST-1589 EST-1589

Objectives

I.  Evaluate the antitumor efficacy (response rate and survival) and toxicity 
of merbarone vs. piroxantrone vs. taxol (taxol arm closed as of 3/91) in 
patients with advanced non-small cell lung cancer who have had no prior 
cytotoxic chemotherapy.
II.  Monitor the quality of life of this patient population treated with these 
drugs by collecting pain, performance status, weight change, and nausea and 
vomiting data with each course of chemotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with 
histologically confirmed Stage IV non-small cell bronchogenic carcinoma 
(adenocarcinoma and squamous and large cell anaplastic carcinoma) who have had 
no prior chemotherapy and no more than one prior biologic regimen.  Tumors of 
mixed type are categorized by the predominant cell type, but presence of small 
cell anaplastic elements excludes; sputum cytology alone is not acceptable 
evidence of cell type, but specimens obtained by brushing, washing, or needle 
aspiration of a defined lesion are acceptable.  A CT scan or MRI documenting 
the absence of CNS metastases is required prior to entry.  Patients with 
ipsilateral intrathoracic nodal disease as their only evidence of metastatic 
disease are ineligible.  Measurable disease outside any previous radiotherapy 
port is required; to be considered measurable, lesions must be clearly defined 
by x-ray (including computerized and routine tomography) or physical 
examination in at least 2 dimensions.  Hepatomegaly is acceptable as 
measurable disease provided the liver has been proven to contain metastases 
and a clearly palpable liver edge extends at least 5 cm below the xiphoid 
process or costal margins on quiet respiration.  Bone scans are not acceptable 
as the sole measures of disease.  Patients with a known or suspected 
hypersensitivity to agents that use Cremophor in their formulation are 
ineligible, as are those who will have to remain on allopurinol during the 
study.  At least 2 weeks must have elapsed since prior radiotherapy, and the 
patient must have recovered from the side effects of such therapy.  An ECOG 
performance status of 1 or better is required, as is documentation of adequate 
bone marrow, liver, and kidney function within 2 weeks prior to entry:  WBC at 
least 4,000 and platelets at least 100,000; bilirubin no more than 1.5 mg/dl 
and SGOT no more than twice normal; and BUN no more than 25 mg/dl and 
creatinine no more than 1.5 mg/dl.  Patients with cardiac disease, defined as 
follows, are ineligible:  uncontrolled hypertension, unstable angina, 
congestive heart failure, myocardial infarction within the previous year, and 
serious cardiac arrhythmias requiring medication.  Uncontrolled diabetes 
mellitus (defined as a random blood sugar of 200 mg/dl or higher), a prior 
history of uncontrolled malignancies other than skin cancer, and uncontrolled 
active infections exclude.  Patients must be able to tolerate intensive 
treatment medically and psychologically and must be accessible for follow-up; 
alcoholics and drug addicts may be placed on study at the investigator's 
discretion.

Expected Enrollment

25 patients will be entered on the Taxol arm, and 40 evaluable patients will 
be studied on each of the other arms.  Accrual to Arm I was temporarily 
suspended from 06/14/90 to 06/25/90 because of problems with purity testing.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy.  Merbarone, MERB, NSC-336628.
Arm II:  Single-agent Chemotherapy.  Piroxantrone, PXT, NSC-349174.
Arm III (arm closed as of 3/91):  Single-agent Chemotherapy.  Taxol, TAX, 
NSC-125973.

Chang AY, Kim K, Glick J, et al.: Phase II study of taxol, merbarone, and piroxantrone in stage IV non-small-cell lung cancer: The Eastern Cooperative Oncology Group Results. J Natl Cancer Inst 85 (5): 388-94, 1993.[PUBMED Abstract]

Chang A, Kim K, Glick J, et al.: Phase II study of taxol in patients with stage IV non-small cell lung cancer (NSCLC): the Eastern Cooperative Oncology Group (ECOG) results. [Abstract] Proceedings of the American Society of Clinical Oncology 11: A-981, 1992.

Ettinger DS: Taxol in the treatment of lung cancer. J Natl Cancer Inst Monogr (15): 177-9, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Alex Chang, MD, Protocol chair		Ph: 65-6880-2222 Email: alexchang@imc.jhmi.edu