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 Hospital Indianapolis, Indiana  46202
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Rapid City Regional Hospital Rapid City, South Dakota  57709
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
New York Methodist Hospital Brooklyn, New York  11215-3609
CCOP - Columbus Columbus, Ohio  43206
CCOP - Greenville Greenville, South Carolina  29615
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53201-2901
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
SUNY Downstate Medical Center Brooklyn, New York  11203
Central Baptist Hospital Lexington, Kentucky  40503
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
General Robert Huyser Cancer Center at David Grant Medical Center Travis Air Force Base, California  94535
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Mount Carmel Health - West Hospital Columbus, Ohio  43222
All Saints Cancer Center at Wheaton Franciscan Healthcare Racine, Wisconsin  53405
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Highland Hospital of Rochester Rochester, New York  14620
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wood County Oncology Center Bowling Green, Ohio  43402
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
Great Lakes Cancer Institute at McLaren Regional Medical Center Flint, Michigan  48532
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
West Allis Memorial Hospital West Allis, Wisconsin  53227
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Grant Medical Center Cancer Care Columbus, Ohio  43215
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
Arizona Oncology Services Foundation Phoenix, Arizona  85013
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center Pomona, California  91767
Cancer Treatment Center for Southern Kentucky Bowling Green, Kentucky  42101
Rex Cancer Center at Rex Hospital Raleigh, North Carolina  27607
Wilmed Radiation Oncology Services Wilson, North Carolina  27893
Trinity CancerCare Center Minot, North Dakota  58701
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Cancer Centers of North Carolina - Raleigh Raleigh, North Carolina  27607
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Central Maine Comprehensive Cancer Center at Central Maine Medical Center Lewiston, Maine  04240
Saint John's Cancer Center at Saint John's Medical Center Anderson, Indiana  46016