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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000346366 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arsenic trioxide | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), meeting criteria for 1 of the following:
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
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
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Dennie V. Jones, MD | University of Texas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555-0209 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |