Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017082
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-06-06
Brief Title:
Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
Prologue Research International
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-12
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
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the overall response rate onset and duration of partial and complete responses and duration of stable disease in patients with recurrent metastatic colorectal cancer treated with oxaliplatin II Determine the overall survival of patients treated with this drug III Determine the proportion of patients with tumor-related symptomatic improvement and time to tumor-related symptomatic worsening in patients treated with this drug IV Determine the time to disease progression in patients treated with this drug V Determine the proportion of patients achieving stable disease when treated with this drug VI Determine the safety of this drug in this patient population
OUTLINE This is a multicenter study Patients receive oxaliplatin IV over 120 minutes on day 1 Courses repeat every 3 weeks for up to 1 year in the absence of disease progression Patients are followed at 30 days and then every 8 weeks for 10 months
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oxaliplatin IV over 120 minutes on day 1 Courses repeat every 3 weeks for up to 1 year in the absence of disease progression Patients are followed at 30 days and then every 8 weeks for 10 months
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| SANOFI-EFC4759 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068647 | REGISTRY | None | None |