Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022347
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-08-10
Brief Title:
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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 TLK286 in treating patients who have advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer treated with TLK286 II Determine the safety of this regimen in these patients III Determine the duration of objective response time to tumor progression and overall survival in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive TLK286 IV over 30 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 12 months
OUTLINE This is a multicenter study Patients receive TLK286 IV over 30 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 12 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-G01-1998 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-01059 | None | None | None |
| CDR0000068807 | REGISTRY | None | None |