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(s) targeted: Lung Cancer; Pulmonary Complications; Radiation Fibrosis

Intervention: captopril (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Radiation Therapy Oncology Group

Official(s) and/or principal investigator(s):
William Small, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center

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.

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Incidence of therapy-induced lung toxicity

Secondary outcome:

Correlation of lung toxicities with biochemical markers

Correlation of quality of life with late effects as measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or LC-13

Pulmonary toxicity at 2 years after completion of study treatment

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

Mobile Infirmary Medical Center, Mobile, Alabama 36652-2144, United States

Arizona Oncology Services Foundation, Phoenix, Arizona 85013, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California 91505, United States

Veterans Affairs Medical Center - Long Beach, Long Beach, California 90822, United States

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona, California 91767, United States

General Robert Huyser Cancer Center at David Grant Medical Center, Travis AFB, California 94535-1800, United States

University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado 80045, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida 33176, United States

Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois 62002, United States

Good Samaritan Regional Health Center, Mt. Vernon, Illinois 62864, United States

Saint John's Cancer Center at Saint John's Medical Center, Anderson, Indiana 46016, United States

Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana 46202, United States

Cancer Treatment Center for Southern Kentucky, Bowling Green, Kentucky 42101, United States

Central Baptist Hospital, Lexington, Kentucky 40503-9985, United States

Central Maine Comprehensive Cancer Center at Central Maine Medical Center, Lewiston, Maine 04240, United States

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland 21201, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan 48202, United States

Great Lakes Cancer Institute at McLaren Regional Medical Center, Flint, Michigan 48532, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville, Michigan 48144, United States

Community Cancer Center of Monroe, Monroe, Michigan 48162, United States

Mercy Memorial Hospital - Monroe, Monroe, Michigan 48162, United States

William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States

Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi 39581, United States

Saint Francis Medical Center, Cape Girardeau, Missouri 63703, United States

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri 63701, United States

David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri 63141, United States

CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri 63141, United States

Monmouth Medical Center, Long Branch, New Jersey 07740-6395, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States

J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River, New Jersey 08755, United States

New York Methodist Hospital, Brooklyn, New York 11215, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center, Plattsburgh, New York 12901, United States

Highland Hospital of Rochester, Rochester, New York 14620, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States

Wayne Radiation Oncology, Goldsboro, North Carolina 27534, United States

Cancer Centers of North Carolina - Raleigh, Raleigh, North Carolina 27607, United States

Rex Cancer Center at Rex Hospital, Raleigh, North Carolina 27607, United States

Wilmed Radiation Oncology Services, Wilson, North Carolina 27893, United States

Trinity CancerCare Center, Minot, North Dakota 58701, United States

Wood County Oncology Center, Bowling Green, Ohio 43402, United States

Adena Regional Medical Center, Chillicothe, Ohio 45601, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States

Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

Grady Memorial Hospital, Delaware, Ohio 43015, United States

Fremont Memorial Hospital, Fremont, Ohio 43420, United States

Fairfield Medical Center, Lancaster, Ohio 43130, United States

Lima Memorial Hospital, Lima, Ohio 45804, United States

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio 45750, United States

Northwest Ohio Oncology Center, Maumee, Ohio 43537, United States

St. Luke's Hospital, Maumee, Ohio 43537, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio 43055, United States

St. Charles Mercy Hospital, Oregon, Ohio 43616, United States

Toledo Clinic - Oregon, Oregon, Ohio 43616, United States

Firelands Regional Medical Center, Sandusky, Ohio 44870, United States

North Coast Cancer Care, Incorporated, Sandusky, Ohio 44870, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States

Mercy Medical Center, Springfield, Ohio 45504, United States

Flower Hospital Cancer Center, Sylvania, Ohio 43560, United States

Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43617, United States

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States

St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States

Toledo Hospital, Toledo, Ohio 43606, United States

Fulton County Health Center, Wauseon, Ohio 43567, United States

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio 43081, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio 43701, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States

Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia 22401, United States

Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin 53097, United States

Columbia-Saint Mary's Cancer Care Center, Milwaukee, Wisconsin 53211, United States

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center, Milwaukee, Wisconsin 53215, United States

All Saints Cancer Center at Wheaton Franciscan Healthcare, Racine, Wisconsin 53405, United States

West Allis Memorial Hospital, West Allis, Wisconsin 53227, United States

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

Starting date: June 2003
Last updated: March 26, 2015