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A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Edward F. McClay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Pacific Oncology & Hematology Associates

Authority:

Unspecified

Study ID:

CDR0000551557

NCT ID:

NCT00538005

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasEncinitas, California  92024