A Phase 1/2 interventional study of bevacizumab and oxaliplatin in Melanoma (Skin), sponsored by San Diego Pacific Oncology & Hematology Associates. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.
Sponsored by San Diego Pacific Oncology & Hematology Associates · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
After completion of study therapy, patients are followed for at least 5 years.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 54 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →San Diego Pacific Oncology & Hematology Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Measurable or evaluable non-CNS disease
Evaluable disease, defined as a lesion that can be seen radiographically but is not unidimensionally measurable
No active brain metastases
Previously treated, responding brain metastases allowed, provided there is measurable disease outside of the CNS
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Response (complete and partial) as assessed by RECIST criteria
Progression-free survival
Overall survival
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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San Diego Pacific Oncology & Hematology Associates