Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075426
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2004-01-09
Brief Title:
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
A Pilot Phase II Protocol Of Arsenic Trioxide Trisenox In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000346366 | None | None | None |