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Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma

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. Identifier: NCT00489944
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 21, 2007
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. 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 sunitinib together with tamoxifen and cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib together with tamoxifen and cisplatin works in treating patients with high-risk ocular melanoma.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Drug: cisplatin Drug: sunitinib malate Drug: tamoxifen citrate Procedure: adjuvant therapy Phase 2

Detailed Description:


  • Determine the effect of adjuvant sunitinib malate, tamoxifen citrate, and cisplatin on disease-free survival and overall survival of patients with high-risk ocular melanoma who have undergone primary therapy.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a pilot study.

Patients receive oral sunitinib malate once daily on days 1-21, oral tamoxifen citrate twice daily on days 1-7, and cisplatin IV on days 2 and 3. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months for 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
Official Title: A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma
Study Start Date : May 2007
Estimated Primary Completion Date : December 2012

Primary Outcome Measures :
  1. Disease-free survival
  2. Overall survival
  3. Toxicity

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of ocular melanoma

    • High-risk disease, defined by any of the following:

      • Large choroidal tumors with a basal diameter ≥ 16 mm and/or tumor thickness ≥ 10 mm (T3)
      • Extrascleral extension (T4)
      • Ciliary body involvement
      • Epithelioid cell type only
  • Have undergone appropriate primary treatment for ocular melanoma
  • No measurable metastatic disease


  • ECOG performance status 0-2
  • ANC ≥ 1,200/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
  • AST and ALT ≤ 3 times upper limit of normal
  • Pancreatic enzymes normal
  • Thyroid function normal or stable on replacement therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Cardiac ejection fraction ≥ 50% by MUGA or ECHO
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring medication
  • No history of pulmonary disease requiring supplemental oxygen
  • No dyspnea at rest
  • No active infection
  • No chronic underlying immunodeficiency disease
  • No other serious illness that would preclude patient safety, in the opinion of the investigator
  • No other cancer within the past 5 years except nonmelanoma skin cancer or cervical cancer
  • No thromboembolic disease within the past 6 months


  • No prior sunitinib malate, tamoxifen citrate, or cisplatin
  • No other concurrent chemotherapy, radiotherapy, or surgery

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 identifier (NCT number): NCT00489944

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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   
Sponsors and Collaborators
San Diego Pacific Oncology & Hematology Associates
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Principal Investigator: Edward F. McClay, MD San Diego Pacific Oncology & Hematology Associates
Layout table for additonal information Identifier: NCT00489944    
Other Study ID Numbers: CDR0000551559
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
epithelioid cell intraocular melanoma
stage IIB intraocular melanoma
stage IIIA intraocular melanoma
stage IIIB intraocular melanoma
stage IIIC intraocular melanoma
stage IV intraocular melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents