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

NCT ID: NCT00489944

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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.

Detailed 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.

Conditions

Intraocular Melanoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

sunitinib malate

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego Pacific Oncology & Hematology Associates

OTHER

Sponsor Role: lead

Principal Investigators

Edward F. McClay, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Pacific Oncology & Hematology Associates

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Edward F. McClay, MD

Role: primary

emcclay@pacificoncology.com

760-452-3340

Other Identifiers

POHA-0604

Identifier Type: -

Identifier Source: secondary_id

CDR0000551559

Identifier Type: -

Identifier Source: org_study_id