• Incidence of therapy-induced lung toxicity
  
• Correlation of lung toxicities with biochemical markers
  
• Correlation of quality of life with late effects as measured by EORTC C-30 or LC-13
  
• Pulmonary toxicity at 2 years after completion of study treatment
  

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
• SGOT less than 2 times normal

Renal

• 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