Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer
PRIMARY OBJECTIVES:
I. Determine the frequency of major response in patients with metastatic renal cell cancer
treated with bevacizumab and interleukin-2.
SECONDARY OBJECTIVES I. Compare the median progression-free survival and median overall
survival of patients treated with this regimen with risk-stratified historical controls from
published risk models.
OUTLINE:
Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11.
Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment
repeats every 12 weeks for up to 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab
alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 3
months for at least 2 years.
PROJECTED ACCRUAL: Approximately 10-38 patients will be accrued for this study within 21
months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Major response (complete response [CR] and partial response [PR]) according to RECIST
An exact one-sided 95% confidence interval for the major response rate will be computed using the method of Clopper and Pearson.
Up to 2 years
No
Mayer Fishman
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
NCI-2012-02663
NCT00126490
March 2005
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |