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
Condition: Lung Cancer; Pulmonary Complications; Radiation Fibrosis
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Fibrosis; Radiation Fibrosis Syndrome
Intervention: captopril
Intervention description: Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).
Intervention MeSH terms: Captopril
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation fibrosis; pulmonary complications; limited stage small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage I non-small cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        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