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| ID | Type | Description | Link |
|---|---|---|---|
| POHA-0603 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | |||
| oxaliplatin | Drug | |||
| sorafenib tosylate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Measurable or evaluable non-CNS disease
Measurable disease, defined as a unidimensionally measurable lesion as determined by physical exam, x-ray, CT scan, MRI, or other radiographic procedure
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:
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| Name | Affiliation | Role |
|---|---|---|
| Edward F. McClay, MD | San Diego Pacific Oncology & Hematology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Recruiting | Encinitas | California | 92024 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |