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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Medical Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2004
Last Updated
February 11, 2013
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00075426
Brief Title
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title
A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arsenic trioxide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennie V. Jones, MD
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States

12. IPD Sharing Statement

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

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