Clinical Trial: AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer
Brief Summary: 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
Detailed Summary:
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 foll
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 12 months ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Original Primary Outcome:
Current Secondary Outcome: Progression-free Survival [ Time Frame: Up to 2 years ]
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: January 10, 2006
Date Started: October 2005
Date Completion:
Last Updated: October 9, 2015
Last Verified: January 2013
