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

Primary Purpose

Melanoma (Skin)

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

bevacizumab

oxaliplatin

sorafenib tosylate

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasRecruiting

Outcomes

Primary Outcome Measures

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

Response (complete and partial) as assessed by RECIST criteria

Progression-free survival

Overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00538005

First Posted

October 1, 2007

Last Updated

January 9, 2014

Sponsor

San Diego Pacific Oncology & Hematology Associates

1. Study Identification

Unique Protocol Identification Number

NCT00538005

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

San Diego Pacific Oncology & Hematology Associates

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

bevacizumab

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Type

Drug

Intervention Name(s)

sorafenib tosylate

Primary Outcome Measure Information:

Title

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

Title

Response (complete and partial) as assessed by RECIST criteria

Title

Progression-free survival

Title

Overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Organizational Affiliation

San Diego Pacific Oncology & Hematology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Phone

760-452-3340

emcclay@pacificoncology.com

12. IPD Sharing Statement

Learn more about this trial

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

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