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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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Radiation Therapy Oncology Group
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
Cancer-Related Problem/Condition
Lung Cancer
Drug: captopril
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Captopril   

U.S. FDA Resources

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

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

Show 87 study locations  Show 87 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     William Small, MD     Robert H. Lurie Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000315569, RTOG-0123, RTOG-L-0123
First Received:   February 10, 2004
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00077064
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Captopril
Non-small cell lung cancer
Carcinoma, Neuroendocrine
Fibrosis
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neuroepithelioma
Radiation Pneumonitis
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 19, 2008




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