A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Safety Issue:
Yes
Principal Investigator
Edward F. McClay, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
San Diego Pacific Oncology & Hematology Associates
Authority:
Unspecified
Study ID:
CDR0000551557
NCT ID:
NCT00538005
Start Date:
May 2007
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Encinitas, California 92024 |
