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Lung CancerPhase 2NCT00077064

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

A Phase 2 study testing captopril in people with Lung Cancer and Pulmonary Complications, run by Radiation Therapy Oncology Group at 87 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
captopril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
87 sitesUnited States
Study dates
Jun 2003to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Cancer Treatment Center for Southern Kentucky

    Bowling Green, Kentucky, 42101

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Cancer Centers of North Carolina - Raleigh

    Raleigh, North Carolina, 27607

  • Rex Cancer Center at Rex Hospital

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • General Robert Huyser Cancer Center at David Grant Medical Center

    Travis Air Force Base, California, 94535-1800

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • West Allis Memorial Hospital

    West Allis, Wisconsin, 53227

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Wilmed Radiation Oncology Services

    Wilson, North Carolina, 27893

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
captopril
Keywords
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
Medical subject headings
Lung Neoplasms, Radiation Fibrosis Syndrome, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • captoprilDrug

    Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).

Study groups in NCT00077064
Study groupRoleWhat they receive
ObservationNo interventionClinical observation
CaptoprilExperimentalCaptopril
Receives: Drug: captopril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Therapy-induced Lung Toxicity

    Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.

    Measured: Once all patients have been followed for at least 12 months

Secondary outcomes (3)

  1. Correlation of Lung Toxicities With Biochemical Markers

    Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.

    Measured: Once all patients have been followed for at least 12 months

  2. Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13)

    Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.

    Measured: Baseline to 18 months post treatment

  3. Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment

    Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.

    Measured: 2 years from completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2004 (estimated)
  2. Study startJun 2003
  3. Primary completionNov 2008
  4. Study completionDec 2016

Why it stopped: Due to unmet accrual/randomization goals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077064
Sponsor's protocol ID
RTOG-0123
Other IDs
CDR0000315569, RTOG-L-0123
Status last verified
Feb 2018
First submitted
10 Feb 2004
Last updated
8 Mar 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing captopril in people with Lung Cancer and Pulmonary Complications, run by Radiation Therapy Oncology Group at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Therapy-induced Lung Toxicity (time frame: Once all patients have been followed for at least 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.

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