Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2007 |
A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma
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.
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.
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.
- 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.
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
We found this trial at
1
site
Encinitas, California 92024
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