Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-12 @ 5:01 AM
Study NCT ID:
NCT00087334
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2004-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Phase I/II 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Withdrawn due to poor/low accrual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 I/II 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 I/II 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: