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

Sponsor:	University of Texas
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075426

Purpose

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	Intervention	Phase
Lung Cancer	Drug: arsenic trioxide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung

Resource links provided by NLM:

MedlinePlus related topics: Arsenic Cancer Lung Cancer

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	November 2002
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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/mm^3
Platelet count greater than 100,000/mm^3

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075426

Locations

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209

Sponsors and Collaborators

University of Texas

Investigators

Study Chair:

Dennie V. Jones, MD

University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000346366, UTMB-02402
Study First Received:	January 9, 2004
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00075426 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Arsenic trioxide
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009