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

NCT00489944 | Unknown Phase 2

• 2 other identifiers: CDR0000551559POHA-0604
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Disease-free survival

• Overall survival

• Toxicity

Interventions

cisplatin DRUG

sunitinib malate DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• San Diego Pacific Oncology & Hematology Associates: lead

Study Sites (1)

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, 92024, United States

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Cisplatin; Sunitinib; Tamoxifen; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Edward F. McClay, MD

  San Diego Pacific Oncology & Hematology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2012
• Last Updated: January 10, 2014

Record last verified: 2009-07

Locations

US (1)