A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
18 Years
N/A
Both
Lung Cancer
Trial Information
A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Dennie V. Jones, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas
Authority:
United States: Federal Government
Study ID:
02-402
NCT ID:
NCT00075426
Start Date:
November 2002
Completion Date:
July 2005
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
