Clinical Trials /

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

NCT00489944

Description:

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.

Related Conditions:
  • Ocular Melanoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
  • Official Title: A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma

Clinical Trial IDs

  • ORG STUDY ID: CDR0000551559
  • SECONDARY ID: POHA-0604
  • NCT ID: NCT00489944

Conditions

  • Intraocular Melanoma

Interventions

DrugSynonymsArms
cisplatin
sunitinib malate
tamoxifen citrate

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:San Diego Pacific Oncology & Hematology Associates

Trial 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

Last Updated

January 9, 2014