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

• ClinicalTrials.gov Identifier: NCT00489944
• Recruitment Status: Unknown
• First Posted: June 21, 2007
• Last Update Posted: January 10, 2014
• Sponsor: San Diego Pacific Oncology & Hematology Associates
• Information provided by: National Cancer Institute (NCI)

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 (Clinical Trial)
• Estimated 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 2007
• Estimated Primary Completion Date: December 2012

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Disease-free survival
2. Overall survival
3. Toxicity

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas; Recruiting

Encinitas, California, United States, 92024

Contact: Edward F. McClay, MD 760-452-3340 emcclay@pacificoncology.com

Sponsors and Collaborators

San Diego Pacific Oncology & Hematology Associates

Investigators

• Principal Investigator: Edward F. McClay, MD; San Diego Pacific Oncology & Hematology Associates

More Information

• ClinicalTrials.gov Identifier: NCT00489944
• Other Study ID Numbers: CDR0000551559; POHA-0604
• First Posted: June 21, 2007
• Last Update Posted: January 10, 2014
• Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):

ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; epithelioid cell intraocular melanoma; stage IIB intraocular melanoma; stage IIIA intraocular melanoma; stage IIIB intraocular melanoma; stage IIIC intraocular melanoma; stage IV intraocular melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Tamoxifen; Sunitinib; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Bone Density Conservation Agents