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

Lung Cancer Clinical Trial

Official title:

A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075426
• Other study ID #: 02-402
• Secondary ID: CDR0000346366
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: February 11, 2013
• Start date: November 2002
• Est. completion date: July 2005

Study information

• Verified date: February 2013
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States,