The Combination of Radiotherapy With the Anti-Angiogenic Agent Tetrathiomolybdate (TM) in the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase I Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting
the following criteria:

- Squamous, large cell undifferentiated, or adenocarcinoma

- Sputum cytology not acceptable evidence of cell type

- Cytologic specimens obtained by brushing, washing, or needle aspiration of
a defined lesion allowed

- Stage I-IIIB disease

- No evidence of distant metastases

- Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for
gross residual disease or positive margin)

- Medically inoperable disease or chemotherapy or surgery refused

- Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan,
unless definitive CT-positive mediastinal disease is noted

- If patient cannot tolerate mediastinoscopy and no PET is available, the
technetium 99m sestamibi scan is allowed for assessment of the mediastinum

- No stage IIIB disease with pleural effusions or stage IV disease

- No small cell lung cancer or mixed small cell/non-small cell histology

PATIENT CHARACTERISTICS:

- SWOG performance status 0-2

- Hemoglobin ≥ 9.0 g/dL

- WBC ≥ 3,000/mm³

- ANC ≥ 1,200/mm³

- Platelet count ≥ 80,000/mm³

- Creatinine < 1.8 mg/dL

- Prior malignancy allowed if disease free for ≥ 5 years

- Nonmelanoma skin cancer allowed within 5 years

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the
radiation oncologist has concerns about a 3-week delay in treatment)

- No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction
where the radiation oncologist has concerns about a 3-week delay in treatment)

- No transfusion dependence requiring > 2 units of packed RBCs every 2 weeks for more
than 28 days

- No medically serious acute or chronic medical condition that is unstable and/or
requires intensive management

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior thoracic radiation allowed if the new lesion can be treated with absolutely no
overlap of previous treatment fields

- At least 3 weeks since prior surgery

- No concurrent chemotherapy