Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080951
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2004-04-07
Brief Title:
Irinotecan Fluorouracil Leucovorin and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Of Irinotecan 5-Fluorouracil Leucovorin Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as irinotecan fluorouracil leucovorin and oxaliplatin work in 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 combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan fluorouracil leucovorin calcium and oxaliplatin as first-line treatment
Secondary
Determine the time to tumor progression time to treatment failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
Determine whether UGT1A1 polymorphism is related to toxicity especially leukopenia diarrhea or neutropenia or response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each chemotherapy course and at the end of treatment
Patients are followed every 3 months until 5 years after registration
Primary
Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan fluorouracil leucovorin calcium and oxaliplatin as first-line treatment
Secondary
Determine the time to tumor progression time to treatment failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
Determine whether UGT1A1 polymorphism is related to toxicity especially leukopenia diarrhea or neutropenia or response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each chemotherapy course and at the end of treatment
Patients are followed every 3 months until 5 years after registration
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-2012-02581 | REGISTRY | None | None |
| CDR0000357571 | REGISTRY | PDQ Physician Data Query | None |