Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: bevacizumab Drug: oxaliplatin Drug: sorafenib tosylate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma |
- Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin [ Designated as safety issue: Yes ]
- Response (complete and partial) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Recruiting |
| Encinitas, California, United States, 92024 | |
| Contact: Edward F. McClay, MD 760-452-3340 emcclay@pacificoncology.com | |
| Principal Investigator: | Edward F. McClay, MD | San Diego Pacific Oncology & Hematology Associates |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00538005 History of Changes |
| Other Study ID Numbers: | CDR0000551557, POHA-0603 |
| Study First Received: | October 1, 2007 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Oxaliplatin Bevacizumab Sorafenib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013