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Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

Primary Purpose

Melanoma (Skin)

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cisplatin

sorafenib tosylate

tamoxifen citrate

adjuvant therapy

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Confirmed diagnosis of melanoma
- High-risk, stage III disease
No measurable metastatic disease
Has undergone surgery within the past 8 weeks
- Surgically rendered disease free

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL
Liver function tests ≤ 3 times the upper limit of normal
ANC ≥ 1,200/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No myocardial infarction within the past 6 months
No congestive heart failure requiring medication
No pulmonary disease requiring supplemental oxygen
No dyspnea at rest
No active infection
No chronic underlying immunodeficiency disease
No other serious illness that, in the physicians' opinion, may compromise the safety of the patient
No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer
No thromboembolic disease within the past 6 months

PRIOR CONCURRENT THERAPY:

No prior tamoxifen citrate, sorafenib tosylate, or cisplatin
No concurrent radiotherapy or surgery

Sites / Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasRecruiting

Outcomes

Primary Outcome Measures

Relapse-free survival

Overall survival

Toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00492505

First Posted

June 25, 2007

Last Updated

January 9, 2014

Sponsor

San Diego Pacific Oncology & Hematology Associates

1. Study Identification

Unique Protocol Identification Number

NCT00492505

Brief Title

Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

Official Title

A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2011 (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 and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as tamoxifen and cisplatin, 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 tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib together with tamoxifen and cisplatin works in treating patients with high-risk stage III melanoma.

Detailed Description

OBJECTIVES: Compare relapse-free and overall survival of patients with high-risk stage III melanoma receiving adjuvant sorafenib tosylate, tamoxifen citrate, and cisplatin vs historical data from patients treated with tamoxifen citrate and cisplatin. Compare the toxicity of these regimens in these patients. OUTLINE: This is a pilot study. Patients are stratified according to number of positive lymph nodes identified during surgery. Patients receive oral sorafenib tosylate twice daily on days 1-28, oral tamoxifen citrate twice daily on days 1-7, and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically 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

stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

sorafenib tosylate

Intervention Type

Drug

Intervention Name(s)

tamoxifen citrate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Relapse-free survival

Title

Overall survival

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Confirmed diagnosis of melanoma High-risk, stage III disease No measurable metastatic disease Has undergone surgery within the past 8 weeks Surgically rendered disease free PATIENT CHARACTERISTICS: ECOG performance status 0-2 Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL Liver function tests ≤ 3 times the upper limit of normal ANC ≥ 1,200/mm³ Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm³ Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No myocardial infarction within the past 6 months No congestive heart failure requiring medication No pulmonary disease requiring supplemental oxygen No dyspnea at rest No active infection No chronic underlying immunodeficiency disease No other serious illness that, in the physicians' opinion, may compromise the safety of the patient No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer No thromboembolic disease within the past 6 months PRIOR CONCURRENT THERAPY: No prior tamoxifen citrate, sorafenib tosylate, or cisplatin No concurrent radiotherapy 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, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

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