Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004922
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-03-07
Brief Title:
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Clinical Trial of Irinotecan CPT-11 in Patients With Advanced High Grade Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors
Detailed Description:
OBJECTIVES
Determine the efficacy of irinotecan in terms of tumor response time to tumor progression and survival in patients with advanced high grade neuroendocrine tumors
Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population
OUTLINE Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed until death
PROJECTED ACCRUAL A total of 10-31 patients will be accrued for this study
Determine the efficacy of irinotecan in terms of tumor response time to tumor progression and survival in patients with advanced high grade neuroendocrine tumors
Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population
OUTLINE Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed until death
PROJECTED ACCRUAL A total of 10-31 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-G00-1683 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067605 | REGISTRY | None | None |