Clinical Trials Directory

Trials / Completed

CompletedNCT00278343

Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer

A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
74 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
19 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well cediranib maleate works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Objective tumor response rate (complete plus partial response plus stable disease \> 16 weeks as defined by the Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer. SECONDARY OBJECTIVES: I. Time to disease progression, median survival time, and duration of overall cancer antigen (CA)-125 response. OUTLINE: Patients receive cediranib maleate orally (PO) once daily (QD) every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Conditions

Interventions

TypeNameDescription
DRUGcediranib maleate30mg given PO, daily
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2006-04-01
Primary completion
2010-06-01
Completion
2018-01-15
First posted
2006-01-18
Last updated
2018-08-29
Results posted
2017-07-02

Locations

28 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00278343. Inclusion in this directory is not an endorsement.