Status:
TERMINATED
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
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Lung Cancer
Pulmonary Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 s...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00077064
Start Date
June 1 2003
End Date
December 1 2016
Last Update
March 8 2018
Active Locations (87)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
3
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
4
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505