Lung Cancer Clinical Trial
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.
Full Description
OBJECTIVES:
Primary
Determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer.
Determine the qualitative and quantitative toxic effects of this drug in these patients.
Secondary
Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
Determine the patterns of failure and survival in patients treated with this drug.
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy beyond CR. Patients achieving CR due to local consolidative therapy (surgery or radiotherapy) receive 2 additional courses of therapy beyond CR.
Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-18 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), meeting criteria for 1 of the following:
Locally advanced disease not amenable to radiotherapy or surgery
Metastatic disease
Received at least 1 course of platinum-based (e.g., cisplatin or carboplatin) chemotherapy
No uncontrolled central nervous system (CNS) metastases
Ineligible for higher priority treatment protocols
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Eastern Cooperative Oncology Group (ECOG) 0-1 OR
Zubrod Scale 0-1 OR
South West Oncology Group (SWOG) 0-1
Life expectancy
At least 12 weeks
Hematopoietic
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 times normal
Serum glutamate oxaloacetate transaminase (SGOT) and Serum glutamate pyruvate transaminase (SGPT) no greater than 3 times normal
Renal
Creatinine no greater than 2.0 mg/dL
Calcium no greater than 12 mg/dL
Cardiovascular
No myocardial infarction within the past 6 months
No uncontrolled, clinically significant dysrhythmia
Cardiac ejection fraction greater than 50%
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Electrolytes (including magnesium) normal
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No prior or ongoing peripheral neuropathy grade 2 or greater
No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent cytokine therapy
Chemotherapy
See Disease Characteristics
No more than 2 prior chemotherapy regimens for NSCLC
No other concurrent chemotherapy
Endocrine therapy
Not specified
Radiotherapy
More than 2 weeks since prior radiotherapy
No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
No concurrent radiotherapy
Concurrent palliative or emergent radiotherapy allowed
Surgery
More than 2 weeks since prior surgery
Other
At least 4 weeks since prior antineoplastic agents for non-malignant conditions (e.g., methotrexate for rheumatoid arthritis)
No concurrent antineoplastic agents for non-malignant conditions
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There is 1 Location for this study
Galveston Texas, 77555, United States
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