Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100828
Status:
TERMINATED
Last Update Posted:
2018-12-06
First Post:
2005-01-06
Brief Title:
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to early stopping rule
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 irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer
PURPOSE This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan
Secondary
Determine the safety and tolerability of this drug in these patients
OUTLINE Patients receive irinotecan IV on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Response is assessed after completion of 4 courses Patients achieving complete response CR or partial response PR receive 2 additional courses beyond CR or PR Patients who have stable disease receive up to 12 total courses
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Primary
Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan
Secondary
Determine the safety and tolerability of this drug in these patients
OUTLINE Patients receive irinotecan IV on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Response is assessed after completion of 4 courses Patients achieving complete response CR or partial response PR receive 2 additional courses beyond CR or PR Patients who have stable disease receive up to 12 total courses
PROJECTED ACCRUAL A total of 33 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 |
|---|---|---|---|
| 04-08-04-02 | OTHER | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |
| P50CA096784 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0459 | None | None | None |
| JHOC-04080402 | None | None | None |
| CDR0000409567 | OTHER | None | None |