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 - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077064

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 II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Captopril

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome 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

Estimated Enrollment:	205
Study Start Date:	June 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077064

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Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
United States, California
General Robert Huyser Cancer Center at David Grant Medical Center
Travis AFB, California, United States, 94535-1800
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Illinois
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
United States, Kentucky
Cancer Treatment Center for Southern Kentucky
Bowling Green, Kentucky, United States, 42101
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, New York
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
New York Methodist Hospital
Brooklyn, New York, United States, 11215
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States, 27607
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wilmed Radiation Oncology Services
Wilson, North Carolina, United States, 27893
United States, North Dakota
Trinity CancerCare Center
Minot, North Dakota, United States, 58701
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

William Small, MD

Robert H. Lurie Cancer Center

Study ID Numbers:	CDR0000315569, RTOG-0123, RTOG-L-0123
Study First Received:	February 10, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00077064 History of Changes
Health Authority:	United States: Federal Government