Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006155
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-08-09
Brief Title:
SU5416 and Carboplatin to Treat Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of SU5416 an Antiangiogenesis Agent in Combination With Carboplatin in Patients With Platinum-Refractory Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2000-06
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:
SU5416 a novel antiangiogenesis agent has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 a downstream effector of VEGF in vitro and to inhibit the growth of endothelial cells Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to be inversely related to prognosis in ovarian cancer SU5416 may prove to be a useful agent in this disease Platinum agents currently provide the most effective treatment for ovarian cancer However ovarian cancer often becomes refractory to platinum therapy leaving the patient with a poor prognosis This is a phase I study designed to a determine a dose level of carboplatin to use in combination with an established dose of SU5416 for treatment of patients with platinum-refractory ovarian cancer b assess the side effect profile of SU5416 and carboplatin combination therapy c characterize any alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in combination with carboplatin d characterize carboplatin pharmacokinetic and pharmacodynamic parameters when given in combination with SU5416 e do exploratory studies to assess the effect of SU5416 on platinum-DNA adduct levels f do exploratory studies to assess any alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416 and g obtain preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with platinum-refractory ovarian carcinoma
Detailed Description:
SU5416 a novel antiangiogenesis agent has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 a downstream effector of VEGF in vitro and to inhibit the growth of endothelial cells Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to be inversely related to prognosis in ovarian cancer SU5416 may prove to be a useful agent in this disease Platinum agents currently provide the most effective treatment for ovarian cancer However ovarian cancer often becomes refractory to platinum therapy leaving the patient with a poor prognosis This is a phase I study designed to a determine a dose level of carboplatin to use in combination with an established dose of SU5416 for treatment of patients with platinum-refractory ovarian cancer b assess the side effect profile of SU5416 and carboplatin combination therapy c characterize any alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in combination with carboplatin d characterize carboplatin pharmacokinetic and pharmacodynamic parameters when given in combination with SU5416 e do exploratory studies to assess the effect of SU5416 on platinum-DNA adduct levels f do exploratory studies to assess any alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416 and g obtain preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with platinum-refractory ovarian carcinoma
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 |
|---|---|---|---|
| 00-C-0197 | None | None | None |