Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
Recruitment status was Recruiting
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma |
Drug: cisplatin Drug: sunitinib malate Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma |
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Recruiting |
| Encinitas, California, United States, 92024 | |
| Contact: Edward F. McClay, MD 760-452-3340 emcclay@pacificoncology.com | |
| Principal Investigator: | Edward F. McClay, MD | San Diego Pacific Oncology & Hematology Associates |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00489944 History of Changes |
| Other Study ID Numbers: | CDR0000551559, POHA-0604 |
| Study First Received: | June 20, 2007 |
| Last Updated: | August 26, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases Sunitinib Cisplatin |
Tamoxifen Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013