Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084734
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-06-10
Brief Title:
Docetaxel Capecitabine and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-08
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 docetaxel capecitabine and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel capecitabine and cisplatin in treating patients with metastatic or unresectable solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel capecitabine and cisplatin in treating patients with metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of docetaxel cisplatin and capecitabine in patients with advanced solid tumors
Determine the dose-limiting toxicity and recommended phase II dose of this regimen in these patients
Secondary
Determine the non-dose-limiting toxic effects associated with this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine any clinical activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel cisplatin and 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 At least 6 patients receive treatment at the MTD
PROJECTED ACCRUAL A minimum of 21 patients will be accrued for this study within 15 years
Primary
Determine the maximum tolerated dose of docetaxel cisplatin and capecitabine in patients with advanced solid tumors
Determine the dose-limiting toxicity and recommended phase II dose of this regimen in these patients
Secondary
Determine the non-dose-limiting toxic effects associated with this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine any clinical activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel cisplatin and 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 At least 6 patients receive treatment at the MTD
PROJECTED ACCRUAL A minimum of 21 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| RPCI-RPC-0209 | None | None | None |