Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039390
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2002-06-06
Brief Title:
Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of ZD1839 With Capecitabine in Patients With Advanced Solid Tumors Formerly a Phase I Trial of ZD1839 With Capecitabine and Celecoxib
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of gefitinib and capecitabine in treating patients with advanced solid tumors Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining gefitinib and capecitabine may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
III Determine the pharmacologic profile of this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib and capecitabine
Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 11-41 patients will be accrued for this study within 25 years
I Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
III Determine the pharmacologic profile of this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib and capecitabine
Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 11-41 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| CDR0000069379 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA099176 |
| UCHSC-01479 | None | None | None |
| U01CA099176 | NIH | None | None |