Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer

RUN-IN PERIOD:

Inclusion Criteria:

   - Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0)
   non-small lung cancer (except carcinoid)*

      - Completion of treatment for stage I lung cancer within the past 6 to 36 months
      and currently disease free

      - At least one mediastinal lymph node sampled at resection NOTE: *Southwest
      Oncology Group (SWOG) and Cancer and Leukemia Group B (CALGB) patients must be
      T1, N0; CALGB patients may be T2, N0 provided disease was completely resected
      prior to June 1, 2001 and participation in CALGB 9633 was refused if offered

   - 18 years old and over

   - Eastern Cooperative Oncology Group performance status 0-1

   - Bilirubin no greater than upper limit of normal (ULN)

   - Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
   (SGPT) no greater than ULN

   - Prior mineral, herbal, phytochemical, or vitamin supplementation allowed

   - Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin
   supplementation allowed if schedule and supplementation prior to study remains
   unchanged

Exclusion Criteria:

   - Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks

   - Synchronous lung or non-lung lesions or metastasis, even if resectable

   - History of more than one primary lung cancer at any time

   - Concurrent or other prior cancer within the past 5 years except localized non-melanoma
   skin cancer

   - Prior or concurrent chemotherapy for recurrent lung cancer

   - Prior or concurrent radiotherapy for recurrent lung cancer

   - Concurrent surgery

   - Concurrent supplement(s) containing more than 50 micrograms of selenium

STUDY PHASE:

   - Free of disease

   - Consumed at least 75% of tablets during 4-week run-in period