TerminatedPhase 2NCT00077064

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

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.

Checked against the public recordLast updated Mar 8, 2018 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations87
SponsorRadiation Therapy Oncology Group
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 2
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Drug: captopril
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama
  • Mobile Infirmary Medical CenterMobile, Alabama
  • Arizona Oncology Services FoundationPhoenix, Arizona
  • Providence Saint Joseph Medical Center - BurbankBurbank, California
  • Veterans Affairs Medical Center - Long BeachLong Beach, California
  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California
  • General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California
  • University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
  • University of Florida Shands Cancer CenterGainesville, Florida
  • Baptist-South Miami Regional Cancer ProgramMiami, Florida
  • Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois
  • Good Samaritan Regional Health CenterMount Vernon, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 8, 2018. Always confirm current availability with the study team.

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