Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation
 therapy, and may improve the quality of life of patients with non-small cell lung cancer or
 limited-stage small cell lung cancer.

 PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing
 side effects and improving the quality of life in patients who have received radiation
 therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung
 cancer or limited-stage small cell lung cancer.
OBJECTIVES:

 -  Determine the effect of captopril on the incidence of pulmonary damage at 12 months
 after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small
 cell lung cancer, stage I central non-small cell lung cancer, or limited stage small
 cell lung cancer.

 -  Compare the quality of life of patients treated with captopril vs patients who undergo
 post-radiotherapy observation only.

 -  Determine the persistence of captopril's effect on pulmonary toxicity in these patients.

 OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
 participating center, total lung irradiated (< 25% vs 25-37% vs more than 37%), prior surgery
 (yes vs no), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment
 arms.

 -  Arm I: Patients receive oral captopril 3 times daily for 1 year in the absence of
 disease progression or unacceptable toxicity.

 -  Arm II: Patients undergo observation only for 1 year. Quality of life is assessed at
 baseline and at months 3, 6, 12, and 18.

 Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
 annually thereafter.

 PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study within 18 months.
DISEASE CHARACTERISTICS:

 -  One of the following histologically or cytologically confirmed diagnoses:

 -  Stage II-IIIB non-small cell lung cancer (NSCLC)

 -  Stage I central NSCLC

 -  No peripheral coin lesions

 -  Limited stage small cell lung cancer

 -  Nonmetastatic disease that is receiving radiotherapy and the target is
 confined to a single radiotherapy treatment area

 -  Planning to receive radiotherapy

 -  At least 45 Gy to be delivered to the target volume

 -  More than 25% of total lung volume to receive > 20 Gy if receiving radiotherapy
 alone

 PATIENT CHARACTERISTICS:

 Age

 -  18 and over

 Performance status

 -  Zubrod 0-1

 Hematopoietic

 -  Absolute granulocyte count greater than 1,000/mm^3

 -  Platelet count greater than 75,000/mm^3

 -  Hemoglobin greater than 9.0 g/dL (transfusion allowed)

 Hepatic

 -  Bilirubin less than 1.5 mg/dL

 -  Serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal

 Renal

 -  Blood urea nitrogen (BUN) less than 25 mg/dL

 -  Creatinine less than 1.6 mg/dL

 -  Urine protein less than 10 mg/dL

 -  Urine glucose negative

 Cardiovascular

 -  Systolic blood pressure greater than 110 mm Hg

 -  Diastolic blood pressure greater than 60 mm Hg

 Other

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 -  Sodium normal

 -  Potassium normal

 -  No collagen vascular disease (e.g., lupus or scleroderma)

 -  Rheumatoid arthritis allowed

 -  No known hypersensitivity to ACE inhibitors

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 -  Not specified

 Chemotherapy

 -  Induction or concurrent chemotherapy allowed either during radiotherapy or during
 therapy with captopril

 -  No concurrent methotrexate

 Endocrine therapy

 -  Not specified

 Radiotherapy

 -  See Disease Characteristics

 Surgery

 -  Prior pulmonary lobectomy or segmentectomy allowed

 -  No prior pneumonectomy

 Other

 -  No concurrent angiotensin-converting enzyme (ACE) inhibitors or angiotensin II
 receptor antagonists for hypertension or congestive heart failure

 -  No concurrent lithium

 -  No concurrent procainamide