A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
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 - Encinitas | Encinitas, California 92024 |
