Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
- measure
- Response (complete and partial) as assessed by RECIST criteria
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 surgeryReferences
Publications (0)
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