Fallopian Tube Cancer Clinical Trial
Official title:
A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer
This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PRIMARY OBJECTIVES:
I. To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive
disease, based on either RECIST criteria (for patients with measurable cancer
radiographically) or clinical response benefit (modified Gynecologic Cancer Intergroup
[GCIG] CA-125 response or stable disease for at least 16 weeks).
SECONDARY OBJECTIVES:
I. To assess progression-free survival. II. To assess modified GCIG CA-125 response rate.
III. To assess duration of modified GCIG CA-125 response. IV. To assess the safety of the
recommended phase 2 dose of AZD2171 in this asymptomatic patient population.
V. To explore the pharmacodynamic effects of AZD2171 by correlating clinical outcomes with
an angiogenic profile derived from serial assessments of soluble VEGFR2, circulating
endothelial cell levels, and VEGFR phosphorylation in circulating endothelial cells.
VI. To explore pharmacogenetic differences in kdr/flk-1, HIF1alpha, p53, and endothelial
nitric oxide synthase (eNOS) in PBMCs from subjects who consent separately for
pharmacogenetic studies.
VII. To determine whether oncogenic mutations predict response to AZD2171.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
sensitivity (platinum-sensitive disease vs platinum-insensitive disease).
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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