Expired Study
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Galveston, Texas 77555


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00075426


Primary Contact:

Study Chair
Dennie V. Jones, MD
University of Texas


Backup Contact:

N/A


Location Contact:

Galveston, Texas 77555
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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