Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016978
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With Irinotecan
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin OXAL 5-Fluorouracil 5-FU and Leucovorin CF in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan CPT-11
Status:
COMPLETED
Status Verified Date:
2007-08
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:
Phase II trial to study the effectiveness of combining oxaliplatin fluorouracil and leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with irinotecan 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
Detailed Description:
OBJECTIVES
I Determine the tumor response rate in patients treated with oxaliplatin fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan
II Determine the time to tumor progression time to treatment failure and overall survival of patients treated with this regimen
III Determine the toxicity of this regimen in this patient population IV Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion Quality of life is assessed at baseline approximately every 6-8 weeks during treatment and then after the last course of treatment Patients are followed every 3 months for 5 years
I Determine the tumor response rate in patients treated with oxaliplatin fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan
II Determine the time to tumor progression time to treatment failure and overall survival of patients treated with this regimen
III Determine the toxicity of this regimen in this patient population IV Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion Quality of life is assessed at baseline approximately every 6-8 weeks during treatment and then after the last course of treatment Patients are followed every 3 months for 5 years
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 |
|---|---|---|---|
| CDR0000068638 | REGISTRY | PDQ Physician Data Query | None |
| NCCTG-N9946 | None | None | None |