Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004923
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2000-03-07
Brief Title:
Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2009-08
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors
PURPOSE Phase III trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies II Determine the dose limiting toxicity of this regimen in these patients III Assess any antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation multicenter study of irinotecan Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1 8 15 and 22 Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL Approximately 15-25 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study of irinotecan Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1 8 15 and 22 Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL Approximately 15-25 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 |
|---|---|---|---|
| NCI-G00-1700 | None | None | None |
| YALE-HIC-10023 | None | None | None |