Official Title: “A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma”

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.

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: December 2012

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.

Intervention(s) in this Clinical Trial

• Drug: cisplatin
• Drug: sunitinib malate
• Drug: tamoxifen citrate
• Procedure: adjuvant therapy

Primary Measures

• Disease-free survival
  • Safety Issue?: No
• Overall survival
  • Safety Issue?: No
• Toxicity
  • Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Overall Clinical Trial Officials and Contacts

Edward F. McClay, MD Principal Investigator San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00489944

Study ID Number: CDR0000551559

ClinicalTrials.gov Identifier: NCT00489944

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database