Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
OBJECTIVES:
- Determine the progression-free survival of patients with previously treated metastatic
pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
- Determine the objective response rate and overall survival of patients treated with
these regimens.
- Determine the incidence of thromboembolic events in patients treated with these
regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and
docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
No
Steven J. Cohen, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000316454
NCT00066677
October 2003
April 2009
Name | Location |
---|---|
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |