Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT00006257
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01CA062505 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHNMC-PHI-30 | None | None | View | |
| CHNMC-IRB-99098 | None | None | View | |
| NCI-T99-0086 | None | None | View |