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
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
RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed every 3 months for up to 2 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
Squamous, large cell undifferentiated, or adenocarcinoma
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
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
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: