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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00075426
Recruitment Status : Completed
First Posted : January 12, 2004
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: arsenic trioxide Phase 2

Detailed Description:



  • 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.


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
Study Start Date : November 2002
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic Lung Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 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


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • 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


  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 12 mg/dL


  • No myocardial infarction within the past 6 months
  • No uncontrolled, clinically significant dysrhythmia
  • Cardiac ejection fraction greater than 50%


  • 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


Biologic therapy

  • No concurrent cytokine therapy


  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • 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


  • More than 2 weeks since prior surgery


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075426

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Study Chair: Dennie V. Jones, MD University of Texas
More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00075426     History of Changes
Other Study ID Numbers: 02-402
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by The University of Texas Medical Branch, Galveston:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Arsenic trioxide
Antineoplastic Agents