Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003768
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2000-04-06
Brief Title:
Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2014-01
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 used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of combretastatin A4 phosphate when administered at single doses every 21 days in patients with advanced solid tumors II Determine both the toxicity and dose limiting toxicity of this regimen in these patients III Determine the plasma and urine pharmacokinetics of combretastatin A4 and combretastatin A4 phosphate IV Gather preliminary data regarding possible antitumor effects in those patients with measurable disease
OUTLINE This is an open label dose escalation study Patients receive combretastatin A4 phosphate IV over 10-60 minutes Treatment repeats every 3 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of combretastatin A4 phosphate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 3 weeks
PROJECTED ACCRUAL A maximum of 21 patients will be accrued for this study
OUTLINE This is an open label dose escalation study Patients receive combretastatin A4 phosphate IV over 10-60 minutes Treatment repeats every 3 weeks in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of combretastatin A4 phosphate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 3 weeks
PROJECTED ACCRUAL A maximum of 21 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 |
|---|---|---|---|
| NCI-G99-1502 | None | None | None |
| CWRU-ILEX-1Y98 | None | None | None |
| ILEX-1Y98 | None | None | None |
| ILEX-CA4P101-A3 | None | None | None |