Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The University of Texas Medical Branch, Galveston30 enrolled

Overview

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 * 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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

arsenic trioxideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

Data from ClinicalTrials.gov

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