Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006257
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-09-11
Brief Title:
SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2010-01
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 such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining SU5416 with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in patients with advanced malignancies
Determine the toxicities and pharmacokinetics of this regimen in these patients
Determine the effects of this regimen on a variety of histological and molecular biomarkers of angiogenesis including in vitro activity assays of endothelial cell proliferation migration and invasion
OUTLINE This is a dose escalation study of SU5416
Patients receive SU5416 IV over 1 hour twice weekly during the first week During subsequent courses SU5416 is administered on days 1 4 8 11 15 18 22 and 25 Paclitaxel begins on the second week of therapy and is administered IV over 1 hour on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 12-18 months
Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in patients with advanced malignancies
Determine the toxicities and pharmacokinetics of this regimen in these patients
Determine the effects of this regimen on a variety of histological and molecular biomarkers of angiogenesis including in vitro activity assays of endothelial cell proliferation migration and invasion
OUTLINE This is a dose escalation study of SU5416
Patients receive SU5416 IV over 1 hour twice weekly during the first week During subsequent courses SU5416 is administered on days 1 4 8 11 15 18 22 and 25 Paclitaxel begins on the second week of therapy and is administered IV over 1 hour on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 12-18 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-T99-0086 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |
| U01CA062505 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-30 | None | None | None |
| CHNMC-IRB-99098 | None | None | None |