Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Other	UTMB-02402 NCT00075426

Objectives

Primary

1. Determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer.
2. Determine the qualitative and quantitative toxic effects of this drug in these patients.

Secondary

1. Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
2. Determine the patterns of failure and survival in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 14-30 patients will be accrued for this study within 9-18 months.

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.

Trial Contact Information

Trial Lead Organizations

University of Texas Medical Branch

Dennie Jones, MD, Protocol chair(Contact information may not be current)		Ph: 409-772-1165

Registry Information
Official Title		A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
Trial Start Date		2002-11-15
Trial Completion Date		2005-07-15
Registered in ClinicalTrials.gov		NCT00075426
Date Submitted to PDQ		2003-11-13
Information Last Verified		2006-04-26

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