Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217711
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-09-20
Brief Title:
Oxaliplatin Irinotecan and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Oxaliplatin Irinotecan and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 oxaliplatin irinotecan and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery
PURPOSE This phase III trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer Phase I
Determine the efficacy of this regimen in these patients Phase II
Secondary
Determine the tolerability of this regimen in these patients Phase II
OUTLINE This is a multicenter phase I dose-escalation study of capecitabine followed by a phase II study
Phase I Patients receive oxaliplatin IV over 2 hours on days 1 and 15 irinotecan IV over 1 hour on days 8 and 22 and oral capecitabine twice daily on days 1-29 Treatment repeats every 5 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive capecitabine at the MTD and irinotecan and oxaliplatin as in phase I
After completion of study treatment patients are followed every 2 months for 1 year and then every 4 months thereafter
PROJECTED ACCRUAL A total of 23-32 patients 3-12 for the phase I portion and 20 for the phase II portion will be accrued for this study within 275 years
Primary
Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer Phase I
Determine the efficacy of this regimen in these patients Phase II
Secondary
Determine the tolerability of this regimen in these patients Phase II
OUTLINE This is a multicenter phase I dose-escalation study of capecitabine followed by a phase II study
Phase I Patients receive oxaliplatin IV over 2 hours on days 1 and 15 irinotecan IV over 1 hour on days 8 and 22 and oral capecitabine twice daily on days 1-29 Treatment repeats every 5 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive capecitabine at the MTD and irinotecan and oxaliplatin as in phase I
After completion of study treatment patients are followed every 2 months for 1 year and then every 4 months thereafter
PROJECTED ACCRUAL A total of 23-32 patients 3-12 for the phase I portion and 20 for the phase II portion will be accrued for this study within 275 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 |
|---|---|---|---|
| EU-20524 | None | None | None |