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Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vitamin E (AT)
Isotretinoin
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Current smokers with 20+ packs per year history of smoking OR Former smokers who discontinued smoking 1 year prior to registration (less than 5 cigarettes in the prior year) and had a 20+ packs per year history prior to discontinuing smoking PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 40 IU/mL OR SGPT less than IU/mL Renal: Not specified Other: Fasting triglycerides less than 320 mg/dL No prior malignancy in the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No history of malabsorption syndrome Not pregnant Effective contraception required of all fertile persons PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior isotretinoin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior warfarin or its derivatives At least 3 months since megadose vitamin A (greater than 25,000 IU/day) or beta-carotene greater than 30 mg/day or alpha-tocopherol at least 400 IU daily No concurrent megadose vitamin A (greater than 25,000 IU/day), beta-carotene greater than 30 mg/day, alpha-tocopherol at least 400 IU daily, or other daily supplements and tonics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm I

    Arm II

    Arm Description

    Alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I)

    Isotretinoin orally plus AT placebo orally daily (arm II).

    Outcomes

    Primary Outcome Measures

    Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    February 17, 2012
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00003599
    Brief Title
    Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer
    Official Title
    A Randomized Study of the Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity in a Preliminary Chemoprevention Trial in Former and Current Smokers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn study.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy. PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer.
    Detailed Description
    OBJECTIVES: I. Determine whether the addition of alpha-tocopherol (AT; vitamin E) to isotretinoin decreases the incidence of Grade II and higher toxicity of isotretinoin when administered to former and current smokers. II. Determine the compliance rate of isotretinoin of smoker and former smokers with or without AT over a six month period. III. Determine the feasibility of recruiting former and current smokers with or without AT over a six month period. IV. Determine the effect of isotretinoin administration on serum retinol and retinol-binding protein levels in these patients. OUTLINE: This is randomized, placebo controlled study. Patients are stratified by smoking status (current smoker vs former smoker) and age (less than 50 vs 50 and over). Patients are randomized to be take alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I) or isotretinoin orally plus AT placebo orally daily (arm II). Treatment in each arm continues for 6 months. Patients are followed at 1, 3, 6, and 7 months from start of treatment. PROJECTED ACCRUAL: There will be 300 patients (150 per arm) accrued into this study over an estimated 9 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    non-small cell lung cancer, small cell lung cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    Alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I)
    Arm Title
    Arm II
    Arm Type
    Experimental
    Arm Description
    Isotretinoin orally plus AT placebo orally daily (arm II).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin E (AT)
    Other Intervention Name(s)
    alpha-tocopherol, AT
    Intervention Description
    Orally daily
    Intervention Type
    Drug
    Intervention Name(s)
    Isotretinoin
    Other Intervention Name(s)
    Accutane, 13-cis-Retinoic acid
    Intervention Description
    Orally daily
    Primary Outcome Measure Information:
    Title
    Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Current smokers with 20+ packs per year history of smoking OR Former smokers who discontinued smoking 1 year prior to registration (less than 5 cigarettes in the prior year) and had a 20+ packs per year history prior to discontinuing smoking PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 40 IU/mL OR SGPT less than IU/mL Renal: Not specified Other: Fasting triglycerides less than 320 mg/dL No prior malignancy in the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No history of malabsorption syndrome Not pregnant Effective contraception required of all fertile persons PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior isotretinoin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior warfarin or its derivatives At least 3 months since megadose vitamin A (greater than 25,000 IU/day) or beta-carotene greater than 30 mg/day or alpha-tocopherol at least 400 IU daily No concurrent megadose vitamin A (greater than 25,000 IU/day), beta-carotene greater than 30 mg/day, alpha-tocopherol at least 400 IU daily, or other daily supplements and tonics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodger J. Winn, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    UT MD Anderson Cancer Center Website

    Learn more about this trial

    Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

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