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

Brief Summary

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
  • Study Primary Completion Date: September 2008

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Drug: captopril

Arms, Groups and Cohorts in this Clinical Trial

  • No Intervention: Clinical observation
    • Clinical observation
  • Experimental: Captopril
    • Captopril

Outcome Measures for this Clinical Trial

Primary Measures

  • Incidence of therapy-induced lung toxicity
    • Time Frame: Once all patients have been followed for at least 12 months
      Safety Issue?: Yes

Secondary Measures

  • Correlation of lung toxicities with biochemical markers
    • Time Frame: Once all patients have been followed for at least 12 months
      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
      Safety Issue?: No
  • Pulmonary toxicity at 2 years after completion of study treatment
    • Time Frame: 2 years from completion of study treatment
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Radiation Therapy Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William Small, MD, Study Chair, Robert H. Lurie Cancer Center

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00077064