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

Intraocular Melanoma Clinical Trial

Official title:

A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00489944
• Other study ID #: CDR0000551559
• Secondary ID: POHA-0604
• Status: Recruiting
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: January 9, 2014
• Start date: May 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

PRIOR CONCURRENT THERAPY:

• No prior sunitinib malate, tamoxifen citrate, or cisplatin

• No other concurrent chemotherapy, radiotherapy, or surgery

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

Intervention

Drug:
• cisplatin

• sunitinib malate

• tamoxifen citrate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Pacific Oncology & Hematology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Primary	Overall survival			No
Primary	Toxicity			Yes