Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other POHA-0604 06-04, NCT00489944

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

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

Patient Characteristics:

• 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

Expected Enrollment

Outcomes

Disease-free survival
Overall survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Edward McClay, MD, Principal investigator		Ph: 760-452-3340 Email: emcclay@pacificoncology.com

U.S.A.
California
	Encinitas
	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
		Edward McClay, MD	Ph:  760-452-3340
			Email: emcclay@pacificoncology.com

Registry Information
Official Title		A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients with High-Risk Ocular Melanoma
Trial Start Date		2007-05-07
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00489944
Date Submitted to PDQ		2007-05-15
Information Last Verified		2008-11-16

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