ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia

NCT ID: NCT00522197

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-11-30

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia.

PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.

Detailed Description

OBJECTIVES:

• Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with bronchial intraepithelial neoplasia.
• Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, as well as phase I and II enzyme regulation.
• Establish a library of in vivo confocal microendoscopy images with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents.

OUTLINE: Patients are stratified according to gender. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of ACAPHA.
• Arm II: Patients receive oral placebo twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of placebo. Patients with progressive disease receive ACAPHA twice daily for 6 months.

Patients undergo sputum cytology, oral and bronchial brushings, bronchoalveolar lavage, and bronchial tissue biopsies at baseline and at 6 and 12 months. Samples are analyzed for histopathological and morphometric cell changes; MIB-1 bcl-2, and TUNEL immunostaining; methylation biomarkers; and gene expression analysis of RNA.

After completion of study therapy, patients are followed at 1 and 6 months.

Conditions

Lung Cancer; Precancerous Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ACAPHA

Group Type: ACTIVE_COMPARATOR

multi-herbal agent ACAPHA

Intervention Type: DIETARY_SUPPLEMENT

Sugar Pill

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DIETARY_SUPPLEMENT

Interventions

multi-herbal agent ACAPHA

Intervention Type: DIETARY_SUPPLEMENT

Sugar Pill

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• One or more areas of bronchial intraepithelial neoplasia (IEN) (metaplasia/dysplasia) with a nuclear morphometry index > 1.36 and a surface diameter > 1.2 mm on autofluorescence bronchoscopy
• Atypical sputum cells as determined by computer-assisted image analysis
• Former smoker (i.e., stopped smoking at least 1 year ago) who has smoked at least 30 pack-years (i.e., 1 pack/day for 30 years or more)
• Exhaled carbon monoxide level < 5 ppm
• No invasive cancer on bronchoscopy or abnormal spiral chest CT scan suspicious of lung cancer

PATIENT CHARACTERISTICS:

• ECOG performance status 0 or 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Normal renal function tests (BUN, creatinine, urinalysis)
• Normal liver function tests (AST, ALT, bilirubin, alkaline phosphatase)
• No chronic active hepatitis or liver cirrhosis
• No acute bronchitis or pneumonia within the past month
• No known reaction to xylocaine
• No medical condition that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study, including any of the following:

• Acute or chronic respiratory failure
• Unstable angina
• Uncontrolled congestive heart failure
• Bleeding disorder

PRIOR CONCURRENT THERAPY:

• Not specified

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Lam, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Other Identifiers

U01CA096109

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BCCA-H02-61177-A002

Identifier Type: -

Identifier Source: secondary_id

BCCA-R02-1177

Identifier Type: -

Identifier Source: secondary_id

CDR0000562055

Identifier Type: -

Identifier Source: org_study_id