Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003698
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Solid Tumors
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Combretastatin A4 Phosphate in Patients With Solid Tumours Given by Weekly Intravenous Infusion
Status:
COMPLETED
Status Verified Date:
2008-02
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 malignant solid tumors
PURPOSE Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced malignant solid tumors
Detailed Description:
OBJECTIVES I Determine the toxicity profile including dose limiting toxicity and maximum tolerated dose MTD of combretastatin A4 phosphate in patients with advanced solid malignant tumors II Determine the pharmacokinetics of combretastatin A4 phosphate III Assess the effects of combretastatin A4 phosphate on tumor blood flow using PET and MRI scanning techniques and establish the dose at which these effects occur IV Recommend a dose of combretastatin A4 phosphate for phase II evaluation based on tumor blood flow effect and the MTD V Evaluate possible antitumor effects of this regimen in these patients
OUTLINE This is an open label dose escalation multicenter study Patients receive IV combretastatin A4 phosphate over 10 minutes once a week for 3 weeks Patients not experiencing unacceptable toxic effects begin individual dose escalation receiving a maximum of 3 dose levels with 2 weeks of rest between each dose level Dose escalation stops when 2 patients have experienced dose limiting toxicity DLT at a particular dose level Once DLT is established at least 6 patients are treated at a lower dose to determine the maximum tolerated dose Patients may receive up to 6 courses of 3 infusions each Patients are followed for 4 weeks
PROJECTED ACCRUAL Approximately 30-35 patients will be accrued for this study
OUTLINE This is an open label dose escalation multicenter study Patients receive IV combretastatin A4 phosphate over 10 minutes once a week for 3 weeks Patients not experiencing unacceptable toxic effects begin individual dose escalation receiving a maximum of 3 dose levels with 2 weeks of rest between each dose level Dose escalation stops when 2 patients have experienced dose limiting toxicity DLT at a particular dose level Once DLT is established at least 6 patients are treated at a lower dose to determine the maximum tolerated dose Patients may receive up to 6 courses of 3 infusions each Patients are followed for 4 weeks
PROJECTED ACCRUAL Approximately 30-35 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 |
|---|---|---|---|
| EU-98066 | None | None | None |
| CRC-PHASE-III-PH1066 | None | None | None |