NCT01217398

Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

Detailed description

OBJECTIVES: Primary * To evaluate the efficacy of temozolomide in combination with bevacizumab in treating patients with metastatic uveal melanoma not amenable to curative surgery. Secondary * To determine response rate in these patients. * To determine duration of response in these patients. * To determine progression-free survival of these patients. * To determine overall survival of these patients. * To determine the safety of treatment with this regimen in these patients. * To study the CT perfusion imaging for functional imaging of response in these patients. * To determine the pharmacogenetic influence of constitutional VEGF-A polymorphism on the efficacy and toxicity of bevacizumab. (ancillary) OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and 15-21 and bevacizumab IV over 30-90 minutes on days 8 and 22. Treatment repeats every 28 days for up to 6 courses. Patients achieving at least stable disease then receive bevacizumab monotherapy IV every 2 weeks as maintenance therapy in the absence of unacceptable toxicity and disease progression. Patients undergo CT perfusion imaging at baseline, day 28, and at 3 and 6 months. Blood samples are collected at baseline and then periodically for VEGF-A genetic polymorphism analysis. After completion of study treatment, patients are followed up at 1 month.

Conditions

• Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	temozolomide
GENETIC	polymorphism analysis
OTHER	pharmacogenomic studies

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-10-01
• First posted: 2010-10-08
• Last updated: 2013-08-26

Locations

1 site across 1 country: France