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.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00077064
First received: February 10, 2004
Last updated: October 22, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Incidence of therapy-induced lung toxicity [ Time Frame: Once all patients have been followed for at least 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation of lung toxicities with biochemical markers [ Time Frame: Once all patients have been followed for at least 12 months ] [ Designated as safety issue: No ]
  • Correlation of quality of life with late effects as measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or LC-13 [ Time Frame: Baseline to 18 months post treatment ] [ Designated as safety issue: No ]
  • Pulmonary toxicity at 2 years after completion of study treatment [ Time Frame: 2 years from completion of study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: June 2003
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Clinical observation
Clinical observation
Experimental: Captopril
Captopril
Drug: captopril

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077064

  Show 87 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: William Small, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00077064     History of Changes
Other Study ID Numbers: RTOG-0123, CDR0000315569, RTOG-L-0123
Study First Received: February 10, 2004
Last Updated: October 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Fibrosis
Lung Neoplasms
Radiation Pneumonitis
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Diseases, Interstitial
Lung Injury
Neoplasms
Neoplasms by Site
Pathologic Processes
Radiation Injuries
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Wounds and Injuries
Captopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014