Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311610
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2006-04-05
Brief Title:
Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin
Status:
COMPLETED
Status Verified Date:
2016-06
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 such as liposomal SN-38 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 liposomal SN-38 works in treating patients with metastatic colorectal cancer
PURPOSE This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer
Secondary
Determine the toxicity profile of this drug in these patients
Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity
Determine progression-free survival and overall survival for patients treated with this drug
OUTLINE This is a multicenter study
Patients receive SN-38 liposome IV over 90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 3 years
Primary
Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer
Secondary
Determine the toxicity profile of this drug in these patients
Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity
Determine progression-free survival and overall survival for patients treated with this drug
OUTLINE This is a multicenter study
Patients receive SN-38 liposome IV over 90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 3 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-80402 | None | None | None |
| CDR0000467234 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |