Recruiting
Phase 1
Phase 2

Sorafenib, Bevacizumab, Oxaliplatin

Sponsor:

San Diego Pacific Oncology & Hematology Associates

Code:

NCT00538005

Conditions

Melanoma (Skin)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bevacizumab

oxaliplatin

sorafenib tosylate

Study Details

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.

Conditions

Melanoma (Skin)

Study ID

NCT00538005

Start date

May, 2007

Status verified date

Jul, 2009

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bevacizumab

oxaliplatin

sorafenib tosylate

Primary outcome measure

  • Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin [ Time Frame: undefined ]
  • Response (complete and partial) as assessed by RECIST criteria [ Time Frame: undefined ]
  • Progression-free survival [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]

Central Contacts and Locations

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Edward F. McClay, MD

760-452-3340emcclay@pacificoncology.com

More Information

Sponsor

San Diego Pacific Oncology & Hematology Associates

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

Keywords

  • recurrent melanoma
  • stage IV melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego Pacific Oncology & Hematology Associates on 2014-01-10.