Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084786
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2004-06-10
Brief Title:
Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Dose Escalation of ZD1839 Iressa Days 1 and 2 and Docetaxel Day 3 Every 3 Weeks in Patients With an Advanced Solid Tumor
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:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Giving gefitinib with docetaxel may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors
Determine the safety and efficacy of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib
Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-42 patients will be accrued for this study
Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors
Determine the safety and efficacy of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib
Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-42 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04003 | None | None | None |