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 - Full Text View

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
Lung Cancer Pulmonary Complications Radiation Fibrosis	Drug: captopril	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Captopril

U.S. FDA Resources

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

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

William Small, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000315569, RTOG-0123, RTOG-L-0123
Study First Received:	February 10, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00077064 History of Changes
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
Carcinoma, Neuroendocrine
Fibrosis
Disorders of Environmental Origin
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Angiotensin-Converting Enzyme Inhibitors
Captopril
Lung Diseases, Interstitial
Wounds and Injuries
Cardiovascular Agents
Antihypertensive Agents

Neuroendocrine Tumors
Carcinoma
Protease Inhibitors
Carcinoma, Small Cell
Neuroectodermal Tumors
Lung Diseases
Non-small Cell Lung Cancer
Radiation Pneumonitis
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Pneumonia
Radiation Injuries
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Fibrosis
Neoplasms, Nerve Tissue
Disorders of Environmental Origin
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Angiotensin-Converting Enzyme Inhibitors
Captopril
Respiratory Tract Neoplasms

Lung Diseases, Interstitial
Neoplasms by Histologic Type
Wounds and Injuries
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Radiation Pneumonitis

ClinicalTrials.gov processed this record on July 02, 2009