Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT00084734
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
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 1.5 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 1.5 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RPCI-RPC-0209 | None | None | View |