Status:
COMPLETED
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ar...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00075426
Start Date
November 1 2002
End Date
July 1 2005
Last Update
February 12 2013
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209