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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492505
First Posted: June 27, 2007
Last Update Posted: January 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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
  • Overall survival
  • Toxicity

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00492505     History of Changes
Other Study ID Numbers: CDR0000551556
POHA-0602
First Submitted: June 25, 2007
First Posted: June 27, 2007
Last Update Posted: January 10, 2014
Last Verified: July 2009

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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents


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