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


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

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Safety Issue:

No

Principal Investigator

Edward F. McClay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Pacific Oncology & Hematology Associates

Authority:

Unspecified

Study ID:

CDR0000551556

NCT ID:

NCT00492505

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IIIA melanoma
  • stage IIIB melanoma
  • stage IIIC melanoma
  • Melanoma

Name

Location

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