Lung Cancer Clinical Trial
Official title:
ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis
retinoic acid with or without vitamin E for chemoprevention or observation of cancer in
persons at high risk of developing lung cancer.
OBJECTIVES:
- To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic
acid administered for one year.
- To access the adequacy of the collected specimens for studies of intermediate endpoint
markers.
- to establish a depository of biologic specimens for future studies of new biomarkers.
- Arm 1: Patients receive oral 13-cis retinoic acid daily.
- Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.
- Arm 3: Patients undergo observation only. Treatment continues in arms I and II for
1 year in the absence of unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued
for this study within 3 years.
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