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		SEG-LUN-82284

Objectives

I.  Determine the therapeutic efficacy of ifosfamide in the treatment of 
patients with advanced lung cancer of all cell types that is not amenable to 
treatment with first-line chemotherapy or radical radiotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with a tissue diagnosis of 
carcinoma of the lung of any histologic type (cytologic diagnosis will suffice 
for small cell and squamous cell histologies) who have progressive disease and 
at least one measurable or evaluable lesion.  Brain metastases, pleural 
effusions, and bone metastases are not considered evaluable, and previously 
irradiated lesions must be clearly growing to be considered evaluable.  The 
Karnofsky performance status must be at least 60 percent, and patients must 
have recovered from the toxic effects of previous myelosuppressive therapy.  
Patients with small cell carcinoma must be refractory to a combination 
chemotherapy regimen containing adriamycin, cyclophosphamide, and vincristine, 
although untreated patients with small cell carcinoma are eligible if they 
have extensive bulky disease.  Patients with nonsmall cell carcinoma must not 
be eligible for curative surgery or radical radiotherapy.  No patient may be 
eligible for any ongoing Phase III SECSG study.  Liver, kidney, and bone 
marrow function must be adequate, and there may be no history of a second 
malignancy except for nonmelanomatous skin cancer.

Expected Enrollment

If there is no response among the first 14 patients in each histologic 
stratification group, the study will be terminated for that histologic group; 
if there is a response, an additional 11 patients will be entered.  Protocol 
closed February 1984 because of insufficient accrual.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Ifosfamide, IPP, NSC-109724.

Holoye PY: Ifosfamide plus N-acetylcysteine in the treatment of small cell and non-small cell carcinoma of the lung: a Southeastern Cancer Study Group trial. Cancer Treat Rep 71(4): 431-432, 1987.

Loehrer PJ, Birch R, Kramer BS, et al.: Ifosfamide plus N-acetylcysteine in the treatment of small cell and non-small cell carcinoma of the lung: a Southeastern Cancer Study Group trial. Cancer Treat Rep 70(7): 919-920, 1986.

Trial Contact Information

Trial Lead Organizations

Southeastern Cancer Study Group

George A. Omura, MD, Protocol chair		Ph: 205-444-4617