Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017017
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2001-06-06
Brief Title:
CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Carcinoma
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 III trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer
PURPOSE Phase III trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial fallopian tube or primary peritoneal carcinoma treated with CT-2103
Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients
OUTLINE This is a dose-escalation study
Patients receive CT-2103 IV over 10 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
If no more than 1 of the first 6 patients experience dose-limiting toxicity then the remaining patients receive a higher dose of CT-2103
Patients are followed between 1-3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial fallopian tube or primary peritoneal carcinoma treated with CT-2103
Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients
OUTLINE This is a dose-escalation study
Patients receive CT-2103 IV over 10 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
If no more than 1 of the first 6 patients experience dose-limiting toxicity then the remaining patients receive a higher dose of CT-2103
Patients are followed between 1-3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-40 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 |
|---|---|---|---|
| MSKCC-01024 | None | None | None |
| CDR0000068642 | REGISTRY | None | None |
| NCI-G01-1947 | Registry Identifier | PDQ Physician Data Query | None |