Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye
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.
Genetic: polymorphism analysis
Other: pharmacogenomic studies
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma|
- Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Safety of this regimen in these patients [ Designated as safety issue: Yes ]
- Functional imaging of response by CT perfusion imaging [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
- To evaluate the efficacy of temozolomide in combination with bevacizumab in treating patients with metastatic uveal melanoma not amenable to curative surgery.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217398
|Institut Curie Hopital||Recruiting|
|Paris, France, 75248|
|Contact: Contact Person 33-1-4432-4068 email@example.com|
|Principal Investigator:||Sophie Piperno-Neumann, MD||Institut Curie|