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Status unknownNCT00538005Updated Jan 10, 2014

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

A Phase 1/2 interventional study of bevacizumab and oxaliplatin in Melanoma (Skin), sponsored by San Diego Pacific Oncology & Hematology Associates. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by San Diego Pacific Oncology & Hematology Associates · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
54
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • recurrent melanoma
  • stage IV melanoma
03

In context

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's planned enrollment of 54 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

San Diego Pacific Oncology & Hematology Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Enrollment
54 participants (estimated)

Interventions

  • Biologicalbevacizumab
  • Drugoxaliplatin
  • Drugsorafenib tosylate
06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin

  2. Response (complete and partial) as assessed by RECIST criteria

  3. Progression-free survival

  4. Overall survival

07

Study locations

1 of 1 sites recruiting
  • San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
    Encinitas, California 92024, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00538005
Lead sponsor
San Diego Pacific Oncology & Hematology Associates
First posted
Oct 2, 2007
Start date
May 2007
Primary completion
Jul 2009 (estimated)
Last update
Jan 10, 2014

Study contacts

Edward F. McClay, MD
principal investigator · San Diego Pacific Oncology & Hematology Associates
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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