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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Rodger J. Winn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

DM97-078

NCT ID:

NCT00003599

Start Date:

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms

Name

Location