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, Phase I	Treatment	Completed	18 to 80	NCI	CAN-NCIC-IND17 NCI-T84-0489W, T84-0489, IND17

Objectives

I.  Determine the toxicity and maximum tolerated doses of acivicin and 
cis-platinum when both drugs are administered on a daily for five days 
schedule to previously untreated patients with non-small cell carcinoma of the 
lung.
II.  Determine the antitumor activity of acivicin/cis-platinum in previously 
untreated patients with non-small cell lung cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 to 80 years of age with 
histologically proven non-small cell carcinoma of the lung that is not 
amenable to cure by surgery or radiotherapy, provided they have received no 
prior chemotherapy.  Patients with measurable or evaluable disease (clinically 
or radiographically) are eligible for the Phase I portion of the study; 
patients must have measurable disease for the Phase II study.  Previous 
radiotherapy is allowed only for sites not used to assess response.  The life 
expectancy must be at least 3 months, and the ECOG performance status must be 
0-2.  Hematopoietic and hepatic function must be adequate, and renal function 
must be normal.

Expected Enrollment

About 20 patients will be entered on the Phase I study over 6-9 months.  If 
there is any response among the first 15 evaluable patients in the Phase II 
portion of the study, an additional 10-15 patients will be entered; accrual 
time for the Phase II portion is estimated at 6-9 months (still ongoing as of 
November 1986).

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy.  Acivicin, AT-125, NSC-163501; cis-Platinum, 
CACP, NSC-119875.

Maroun JA, Stewart DJ, Verma S, et al.: Phase I study of acivicin and cisplatin in non-small-cell lung cancer. A National Cancer Institute of Canada study. Am J Clin Oncol 13 (5): 401-4, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Jean Maroun, MD, FRCPC, FRCP, Protocol chair		Ph: 613-737-7700 ext. 70185; 888-627-5346 Email: jmaroun@ottawahospital.on.ca