Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma

NCT ID: NCT00538005

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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.

Detailed Description

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.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

oxaliplatin

Intervention Type: DRUG

sorafenib tosylate

Intervention Type: DRUG

Eligibility Criteria

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

• See Disease Characteristics
• At least 6 weeks since prior radiotherapy
• More than 4 weeks since prior surgery
• Prior biologic therapy allowed

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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego Pacific Oncology & Hematology Associates

OTHER

Sponsor Role: lead

Principal Investigators

Edward F. McClay, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Pacific Oncology & Hematology Associates

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Edward F. McClay, MD

Role: primary

emcclay@pacificoncology.com

760-452-3340

Other Identifiers

POHA-0603

Identifier Type: -

Identifier Source: secondary_id

CDR0000551557

Identifier Type: -

Identifier Source: org_study_id