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

Primary Purpose

Intraocular Melanoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cisplatin

sunitinib malate

tamoxifen citrate

adjuvant therapy

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasRecruiting

Outcomes

Primary Outcome Measures

Disease-free survival

Overall survival

Toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00489944

First Posted

June 20, 2007

Last Updated

January 9, 2014

Sponsor

San Diego Pacific Oncology & Hematology Associates

1. Study Identification

Unique Protocol Identification Number

NCT00489944

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

San Diego Pacific Oncology & Hematology Associates

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

sunitinib malate

Intervention Type

Drug

Intervention Name(s)

tamoxifen citrate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Disease-free survival

Title

Overall survival

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Organizational Affiliation

San Diego Pacific Oncology & Hematology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Phone

760-452-3340

emcclay@pacificoncology.com

12. IPD Sharing Statement

Learn more about this trial

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

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