A Phase II Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865 IND #7921) In the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix (Group A)
OBJECTIVES:
I. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month
progression-free survival (PFS), in patients with persistent or recurrent squamous cell
carcinoma of the cervix.
II. Determine the nature and degree of toxicity of this drug in these patients. III.
Estimate the distribution of PFS and overall survival for patients treated with this drug.
IV. Determine the frequency of clinical response (partial and complete) in patients treated
with this drug.
V. Determine the role of age and initial performance status as prognostic factors in
patients treated with this drug.
VI. Determine whether biological and imaging markers are associated with clinical efficacy
of this drug, such as 6-month PFS, in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Period from study entry until disease progression, death or date of last contact, assessed up to 6 months
No
Bradley Monk
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2012-02416
NCT00025233
April 2002
Name | Location |
---|---|
Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |