Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003276
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
Status:
COMPLETED
Status Verified Date:
2016-07
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 with advanced gallbladder or bile duct cancer that cannot be removed surgically
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients with advanced gallbladder or bile duct cancer that cannot be removed surgically
Detailed Description:
OBJECTIVES I Evaluate the objective tumor response rate in patients with advanced gallbladder or bile duct tumors treated with irinotecan II Evaluate time-to-progression survival and toxic effects associated with irinotecan given weekly for 4 weeks every 6 weeks in this patient population
OUTLINE Patients receive a 90 minute continuous infusion of irinotecan on days 1 8 15 and 22 for 4 weeks followed by a 2 week rest period Courses of treatment are repeated every 42 days Patients continue treatment in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year then every 6 months for the next 4 years
PROJECTED ACCRUAL Approximately 22-40 patients will be accrued for this study over 2-4 years
OUTLINE Patients receive a 90 minute continuous infusion of irinotecan on days 1 8 15 and 22 for 4 weeks followed by a 2 week rest period Courses of treatment are repeated every 42 days Patients continue treatment in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year then every 6 months for the next 4 years
PROJECTED ACCRUAL Approximately 22-40 patients will be accrued for this study over 2-4 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 |
|---|---|---|---|
| CDR0000066181 | REGISTRY | PDQ Physician Data Query | None |