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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00492505
First received: June 25, 2007
Last updated: January 9, 2014
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: cisplatin
Drug: sorafenib tosylate
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Pilot Trial of Sorafenib, Tamoxifen and Cisplatin as Adjuvant Therapy for Patients With Stage III Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492505

Locations
United States, California
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas Recruiting
Encinitas, California, United States, 92024
Contact: Edward F. McClay, MD    760-452-3340    emcclay@pacificoncology.com   
Sponsors and Collaborators
San Diego Pacific Oncology & Hematology Associates
Investigators
Principal Investigator: Edward F. McClay, MD San Diego Pacific Oncology & Hematology Associates
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00492505     History of Changes
Other Study ID Numbers: CDR0000551556, POHA-0602
Study First Received: June 25, 2007
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA melanoma
stage IIIB melanoma
stage IIIC melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Cisplatin
Tamoxifen
Niacinamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on August 19, 2014