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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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
Sponsor: Institut Curie

Current Primary Outcome: Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate
  • Duration of response
  • Progression-free survival
  • Overall survival
  • Safety of this regimen in these patients
  • Functional imaging of response by CT perfusion imaging


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 7, 2010
Date Started: October 2009
Date Completion:
Last Updated: August 23, 2013
Last Verified: August 2012