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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Pulmonary Complications, Radiation Fibrosis

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of therapy-induced lung toxicity

Principal Investigator

William Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000315569

NCT ID:

NCT00077064

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • Pulmonary Complications
  • Radiation Fibrosis
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Fibrosis
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Pneumonitis

Name

Location

Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Rapid City Regional HospitalRapid City, South Dakota  57709
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
New York Methodist HospitalBrooklyn, New York  11215-3609
CCOP - ColumbusColumbus, Ohio  43206
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
SUNY Downstate Medical CenterBrooklyn, New York  11203
Central Baptist HospitalLexington, Kentucky  40503
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California  94535
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Mount Carmel Health - West HospitalColumbus, Ohio  43222
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wood County Oncology CenterBowling Green, Ohio  43402
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Great Lakes Cancer Institute at McLaren Regional Medical CenterFlint, Michigan  48532
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Grant Medical Center Cancer CareColumbus, Ohio  43215
Flower Hospital Cancer CenterSylvania, Ohio  43560
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Cancer Treatment Center for Southern KentuckyBowling Green, Kentucky  42101
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Wilmed Radiation Oncology ServicesWilson, North Carolina  27893
Trinity CancerCare CenterMinot, North Dakota  58701
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Cancer Centers of North Carolina - RaleighRaleigh, North Carolina  27607
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016