Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005647
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2000-05-02
Brief Title:
SU5416 and Paclitaxel in Treating Patients With Recurrent Locally Advanced or Metastatic Cancer of the Head and Neck
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Pharmacokinetic Pharmacodynamic and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2010-06
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:
RATIONALE SU5416 may stop the growth of head and neck 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 cancer cells
PURPOSE Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent locally advanced or metastatic cancer of the head and neck
PURPOSE Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent locally advanced or metastatic cancer of the head and neck
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer
Determine the antiangiogenesis effect of this combination regimen in these patients
Determine the toxicity pharmacodynamic effects and pharmacokinetic parameters of this combination
OUTLINE This is a dose escalation study
Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4 Treatment continues weekly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study within 9-15 months
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer
Determine the antiangiogenesis effect of this combination regimen in these patients
Determine the toxicity pharmacodynamic effects and pharmacokinetic parameters of this combination
OUTLINE This is a dose escalation study
Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4 Treatment continues weekly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study within 9-15 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-T99-0084 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-1399 | None | None | None |