Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00489944

Recruitment Status:

Unknown status

Sponsor:

San Diego Pacific Oncology & Hematology Associates

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There is 1 Location for this study

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San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
Encinitas California, 92024, United States More Info
Edward F. McClay, MD
Contact
760-452-3340
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00489944

Recruitment Status:

Unknown status

Sponsor:


San Diego Pacific Oncology & Hematology Associates

How clear is this clinincal trial information?

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