Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401180
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2006-11-16
Brief Title:
Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease
Status:
COMPLETED
Status Verified Date:
2007-09
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 and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel and temozolomide in treating patients with metastatic cancer
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel and temozolomide in treating patients with metastatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity profile dose-limiting toxicity and maximum tolerated dose of docetaxel and temozolomide TMZ in patients with metastatic cancer
Secondary
Determine the activity of docetaxel and TMZ in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral temozolomide once daily on days 1-21 Treatment repeats every 28 days for up to 1 year in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of docetaxel and temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 6 patients receive treatment at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Primary
Determine the toxicity profile dose-limiting toxicity and maximum tolerated dose of docetaxel and temozolomide TMZ in patients with metastatic cancer
Secondary
Determine the activity of docetaxel and TMZ in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral temozolomide once daily on days 1-21 Treatment repeats every 28 days for up to 1 year in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of docetaxel and temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 6 patients receive treatment at the MTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
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 |
|---|---|---|---|
| CASE-CCF-4737 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |