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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492505

Enrollment

200

Registered

2007-06-27

Start date

2007-04-30

Completion date

Unknown

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma

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.

Interventions

DRUGcisplatin

DRUGsorafenib tosylate

DRUGtamoxifen citrate

PROCEDUREadjuvant therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Relapse-free survival	—
Overall survival	—
Toxicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026