Clinical trial NCT00489944: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Disease-free survival
measure: Overall survival
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
state: California
Study officials:
affiliation: San Diego Pacific Oncology & Hematology Associates
name: Edward F. McClay, MD
role: PRINCIPAL_INVESTIGATOR
References: