Recruiting

Phase 2

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

Sponsor:

San Diego Pacific Oncology & Hematology Associates

Code:

NCT00489944

Conditions

Intraocular Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cisplatin

sunitinib malate

tamoxifen citrate

adjuvant therapy

Study Details

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

Study ID

NCT00489944

Start date

May, 2007

Status verified date

Jul, 2009

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

cisplatin

sunitinib malate

tamoxifen citrate

adjuvant therapy

Primary outcome measure

Disease-free survival [ Time Frame: undefined ]
Overall survival [ Time Frame: undefined ]
Toxicity [ Time Frame: undefined ]

Central Contacts and Locations

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Edward F. McClay, MD

760-452-3340 emcclay@pacificoncology.com

More Information

Sponsor

San Diego Pacific Oncology & Hematology Associates

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego Pacific Oncology & Hematology Associates on 2014-01-10.