Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003726
Status:
TERMINATED
Last Update Posted:
2016-08-08
First Post:
1999-11-01
Brief Title:
Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase III Study of Recombinant Desulfato Hirudin Lepirudin Refludan in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study funding was dropped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Anticoagulants such as lepirudin may help prevent blood clots from forming in patients who have received chemotherapy for small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the dose safety and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy
OUTLINE This is a dose escalation in individual patients study Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached The patient then continues treatment on the maximum tolerated dose Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 18-24 months
OUTLINE This is a dose escalation in individual patients study Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached The patient then continues treatment on the maximum tolerated dose Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 18-24 months
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-V98-1512 | OTHER | NCI | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |
| DMS-9815 | OTHER | None | None |