View Clinical Trial (Medical Research Study)
A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
| City: |
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Encinitas |
| State: |
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California |
| Zip Code: |
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92024 |
| Conditions: |
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Melanoma (Skin) |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Metastatic disease
- 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
- Previously irradiated lesions with documented progression are allowed
provided there are no other sites of metastatic disease
- No active brain metastases
- Previously treated, responding brain metastases allowed, provided there is
measurable disease outside of the CNS
- At least 3 weeks since prior chemotherapy and 6 weeks since prior
radiotherapy for CNS disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,200/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin ≤ 3.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- EKG with no evidence of serious arrhythmia or recent myocardial infarction
Exclusion criteria:
- Active infection
- Chronic underlying immunodeficiency disease
- Other serious concurrent illness
- Other forms of cancer within 5 years of initial diagnosis except nonmelanoma skin
cancer and cervical cancer
- Congestive heart failure or myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- See Disease Characteristics
- At least 6 weeks since prior radiotherapy
- More than 4 weeks since prior surgery
- Prior biologic therapy allowed
Exclusion criteria:
- Prior cytotoxic agents
- Prior sorafenib tosylate, bevacizumab, or oxaliplatin
- Concurrent biological therapy, except growth factors for anemia, neutropenia, or
thrombocytopenia
- Concurrent radiotherapy, chemotherapy, or surgery
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| NCT ID: |
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NCT00538005 |
| Primary Contact: |
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Principal Investigator
Edward F. McClay, MD
San Diego Pacific Oncology & Hematology Associates
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| Backup Contact: |
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N/A |
| Location Contact: |
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Encinitas, California 92024
United States
Edward F. McClay, MD
Phone: 760-452-3340
Email: emcclay@pacificoncology.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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