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

Sponsor

San Diego Pacific Oncology & Hematology Associates (Other)

Overall Status

Unknown status

CT.gov ID

NCT00489944

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

Disease-free survival []
Overall survival []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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