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