Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT00538005
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
San Diego Pacific Oncology & Hematology Associates
Organization:
Study Overview
Official Title:
A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
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: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with bevacizumab and oxaliplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when given together with bevacizumab and oxaliplatin and to see how well it works in treating patients with metastatic malignant melanoma.
PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when given together with bevacizumab and oxaliplatin and to see how well it works in treating patients with metastatic malignant melanoma.
Detailed Description:
OBJECTIVES:
* To determine the maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin.
* To determine the effect of this treatment regimen on the complete and partial response rate in patients with metastatic melanoma.
* To determine the effect of this treatment regimen on the progression-free and overall survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
* Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
* To determine the maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin.
* To determine the effect of this treatment regimen on the complete and partial response rate in patients with metastatic melanoma.
* To determine the effect of this treatment regimen on the progression-free and overall survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
* Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
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 |
|---|---|---|---|---|
| POHA-0603 | None | None | View |