Phase I/II and Pharmacokinetic Study of Docetaxel Plus VEGF Trap (AVE0005, NSC# 724770) in Patients With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of VEGF Trap and docetaxel in patients with
persistent or recurrent ovarian epithelial, primary peritoneal, or fallopian tube cancer.
(Phase I [closed to accrual as of 3/14/2008]) II. Determine the maximum tolerated dose of
VEGF Trap in these patients. (Phase I [closed to accrual as of 3/14/2008]) III. Determine
the pharmacokinetics of VEGF Trap when administered alone and in combination with docetaxel
in these patients. (Phase I [closed to accrual as of 3/14/2008]) IV. Determine the effects
of VEGF Trap on tumor perfusion and metabolism in these patients. (Phase I [closed to
accrual as of 3/14/2008]) V. Determine the effect of VEGF Trap and docetaxel on circulating
endothelial precursors and circulating endothelial cells in these patients. (Phase I [closed
to accrual as of 3/14/2008]) VI. Determine the frequency of clinical response (partial
response and complete response) in patients treated with this regimen. (Phase II [open to
accrual as of 5/9/2008]) VII. Determine the progression-free survival (PFS) and overall
survival (OS) of patients treated with this regimen. (Phase II [open to accrual as of
5/9/2008])
SECONDARY OBJECTIVES:
I. Determine the duration of PFS and OS of patients treated with this regimen. (Phase II)
II. Determine the frequency and severity of adverse effects of this regimen in these
patients. (Phase II) III. Determine the proportion of patients with PFS at 6 months. (Phase
II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of VEGF Trap followed by a
phase II study.
PHASE I (closed to accrual as of 3/14/2008): Patients receive VEGF Trap IV over 1 hour on
day 1 of course 1. Patients then receive VEGF Trap IV over 1 hour and docetaxel IV over 1
hour on day 1 in all subsequent courses. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
or 6 patients experience dose-limiting toxicity.
PHASE II (opened to accrual as of 5/9/2008): Patients receive VEGF Trap at the MTD
determined in phase I and docetaxel as in phase I. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients enrolled in phase I (closed to accrual as of 3/14/2008) undergo blood sample
collection periodically for pharmacokinetic studies and surrogate marker studies. These
patients also undergo dynamic contrast-enhanced MRI, fludeoxyglucose F 18 positron emission
tomography, and CT scan at baseline and on day 1 of courses 1 and 2 to evaluate blood flow
parameters and metabolic activity of tumors. Patients enrolled in phase I (closed to accrual
as of 3/14/2008) and phase II will also undergo blood collection for Anti-VEGF trap
antibody.
After the completion of study treatment, patients are followed at 1 and 2 months and then
periodically thereafter.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of VEGF Trap defined as the highest dose level below which 2 or more patients encounter a DLT, graded according to the NCI CTCAE v3.0 (Phase I)
Up to 21 days
Yes
Robert Coleman
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2009-00218
NCT00436501
January 2007
Name | Location |
---|---|
M D Anderson Cancer Center | Houston, Texas 77030 |