Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004126
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-12-10
Brief Title:
Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in treating patients who have recurrent or advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in treating patients who have recurrent or advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the overall partial and complete response rates in patients with advanced non-small cell lung cancer treated with oxaliplatin plus paclitaxel II Assess the overall survival time to tumor progression and toxicities associated with this combination regimen in this patient population III Assess the neurologic toxicity of this combination regimen and its correlation with creatinine clearance in these patients
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed for at least 2 years or until death
PROJECTED ACCRUAL Approximately 17-37 patients will be accrued for this study within 24 months
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed for at least 2 years or until death
PROJECTED ACCRUAL Approximately 17-37 patients will be accrued for this study within 24 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 |
|---|---|---|---|
| NCI-T99-0008 | None | None | None |
| UCCRC-10014 | None | None | None |