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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00538005
First received: October 1, 2007
Last updated: January 9, 2014
Last verified: July 2009
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538005

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   
Sponsors and Collaborators
San Diego Pacific Oncology & Hematology Associates
Investigators
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: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Bevacizumab
Oxaliplatin
Sorafenib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014