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: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastatic non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer	Drug: arsenic trioxide  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 CNS metastases
• Ineligible for higher priority treatment protocols

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1 OR
• Zubrod 0-1 OR
• 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
• SGOT and 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

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting

Study chairs or principal investigators

Dennie V. Jones, MD,  Study Chair,  University of Texas   

Study ID Numbers:  CDR0000346366; UTMB-02402; NCT00075426
Record last reviewed:  December 2003
Last Updated:  December 6, 2004
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075426
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08