Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087334
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2004-07-08
Brief Title:
Capecitabine Oxaliplatin and Gefitinib in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Study of Capecitabine XELODA Roche Plus Oxaliplatin Eloxatin Sanofi Plus ZD 1893 IRESSA in the Treatment of Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to poorlow accrual
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 capecitabine and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining capecitabine and oxaliplatin with gefitinib 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 gefitinib and to see how well they work in treating patients with metastatic colorectal cancer
PURPOSE This phase III trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and gefitinib and to see how well they work in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer phase I
Determine the response rate in patients treated with this regimen phase II
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine the 1-year survival of patients treated with this regimen phase II
Determine the progression-free and overall survival of patients treated with this regimen phase II
OUTLINE This is an open-label nonrandomized phase I dose-escalation study of capecitabine followed by a phase II study
Phase I Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1 Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment Courses repeat every 21 days 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 oral capecitabine at the MTD determined in phase I oxaliplatin IV and oral gefitinib as in phase I
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 months
Primary
Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer phase I
Determine the response rate in patients treated with this regimen phase II
Secondary
Determine the safety and toxic effects of this regimen in these patients
Determine the 1-year survival of patients treated with this regimen phase II
Determine the progression-free and overall survival of patients treated with this regimen phase II
OUTLINE This is an open-label nonrandomized phase I dose-escalation study of capecitabine followed by a phase II study
Phase I Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1 Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment Courses repeat every 21 days 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 oral capecitabine at the MTD determined in phase I oxaliplatin IV and oral gefitinib as in phase I
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 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 |
|---|---|---|---|
| ZENECA-IRUSIRES0414 | None | None | None |
| RPCI-I-17403 | None | None | None |