Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma
A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
2 other identifiers
interventional
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedJanuary 10, 2014
July 1, 2009
2.2 years
October 1, 2007
January 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- See Disease Characteristics
- At least 6 weeks since prior radiotherapy
- More than 4 weeks since prior surgery
- Prior biologic therapy allowed
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
Encinitas, California, 92024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward F. McClay, MD
San Diego Pacific Oncology & Hematology Associates
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2009
Last Updated
January 10, 2014
Record last verified: 2009-07