Official Title: “A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: captopril

Primary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radiation Therapy Oncology Group

Overall Clinical Trial Officials and Contacts

William Small, MD Study Chair Robert H. Lurie Cancer Center  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00077064

Study ID Number: CDR0000315569

ClinicalTrials.gov Identifier: NCT00077064

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database