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A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Intraocular Melanoma

Thank you

Trial Information

A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Edward F. McClay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Pacific Oncology & Hematology Associates

Authority:

Unspecified

Study ID:

CDR0000551559

NCT ID:

NCT00489944

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • 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
  • Melanoma
  • Uveal Neoplasms

Name

Location

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasEncinitas, California  92024