Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074308
Status:
COMPLETED
Last Update Posted:
2018-06-20
First Post:
2003-12-10
Brief Title:
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of Imatinib Mesylate And Bevacizumab In Patients With Advanced Melanoma And Other Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor Combining imatinib mesylate with bevacizumab may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the tolerability maximum tolerated dose and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancers
II Determine the response rate time to progression and survival of patients treated with this regimen
III Correlate clinical activity with inhibition of platelet-derived growth factor receptor beta vascular endothelial growth factor receptor flt-1 and markers of angiogenesis in patients treated with this regimen
IV Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen
V Correlate toxicity clinical activity and correlative endpoints with the steady-stage plasma concentration of imatinib mesylate in patients treated with this regimen
OUTLINE This is a dose-escalation open-label study
PHASE I closed to accrual as of 82304 Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab 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
PHASE II Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD
I Determine the tolerability maximum tolerated dose and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancers
II Determine the response rate time to progression and survival of patients treated with this regimen
III Correlate clinical activity with inhibition of platelet-derived growth factor receptor beta vascular endothelial growth factor receptor flt-1 and markers of angiogenesis in patients treated with this regimen
IV Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen
V Correlate toxicity clinical activity and correlative endpoints with the steady-stage plasma concentration of imatinib mesylate in patients treated with this regimen
OUTLINE This is a dose-escalation open-label study
PHASE I closed to accrual as of 82304 Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab 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
PHASE II Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD
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 |
|---|---|---|---|
| CDR0000343804 | REGISTRY | PDQ Physician Data Query | None |
| 03903 | None | None | None |