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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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 arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Arsenic Trioxide

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