Clinical Trials Logo

Clinical Trial Summary

This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the response rate (confirmed and unconfirmed, complete and partial response) of patients with stage IV uveal melanoma treated with sorafenib, carboplatin, and paclitaxel.

SECONDARY OBJECTIVES:

I. Determine the overall and progression-free survival of patients treated with this regimen.

II. Determine the toxic effects of this regimen in these patients. III. Determine, preliminarily, the relationship between clinical outcomes and baseline microvessel density (MVD) in tumor specimens, changes in vascular endothelial growth factor (VEGF) levels in plasma and urine, changes in MVD, changes in VEGF receptor-2 phosphorylation in tumor, and/or changes in ERK 1/2 phosphorylation in stimulated lymphocytes and tumor.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice daily on days 2-19. Treatment repeats every 21 days for up to 6 courses.* After 6 courses, patients continue to receive oral sorafenib alone twice daily in the absence of disease progression or unacceptable toxicity.

[Note: *If sorafenib is discontinued prior to course 6, patients may continue to receive carboplatin and paclitaxel for up to 6 courses; if carboplatin and paclitaxel are discontinued prior to course 6, patients may continue to receive sorafenib alone twice daily on days 1-21 of each course in the absence of disease progression or unacceptable toxicity. ]

After completion of study treatment, patients are followed periodically for up to 3 years. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00329641
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date February 2011
Completion date November 2012

See also
  Status Clinical Trial Phase
Completed NCT00121225 - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma Phase 2
Terminated NCT02336763 - Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases N/A
Completed NCT00288041 - Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma Phase 2
Recruiting NCT05628883 - Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma Phase 1
Active, not recruiting NCT02068586 - Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma Phase 2
Completed NCT01100528 - Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance Phase 2
Completed NCT00085189 - Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma Phase 2
Active, not recruiting NCT01143402 - Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye Phase 2
Completed NCT00450255 - VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery Phase 2
Completed NCT00089063 - Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma Phase 2
Completed NCT00243061 - AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma Phase 2
Completed NCT01989572 - Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery Phase 3
Terminated NCT01730157 - Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases Phase 0
Completed NCT01413191 - Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye Phase 2