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
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Pulmonary Complications Radiation Fibrosis |
Drug: captopril |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| 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 |
- 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
| Estimated Enrollment: | 205 |
| Study Start Date: | June 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 87 Study Locations| Study Chair: | William Small, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00077064 History of Changes |
| Other Study ID Numbers: | CDR0000315569, RTOG-0123, RTOG-L-0123 |
| Study First Received: | February 10, 2004 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Fibrosis Lung Neoplasms Small Cell Lung Carcinoma Radiation Pneumonitis Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pathologic Processes |
Lung Diseases, Interstitial Lung Injury Radiation Injuries Wounds and Injuries Captopril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013