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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
30mg given PO, daily
Correlative studies
City of Hope
Duarte, California, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, United States
City of Hope Medical Group Inc
Pasadena, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
University of Chicago
Chicago, Illinois, United States
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR
Time frame: After 16 weeks
Time to Disease Progression
Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.
Time frame: Up to 4 years
Overall Survival (OS) (Discontinued as of 4/25/2014)
The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.
Time frame: From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months.
Progression-free Survival (PFS)
The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.
Time frame: Time from start of treatment to time of progression, assessed up to 6 months
Duration of Overall CA-125 Response
Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by \> 50%.
Time frame: Up to 4 years
Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0
Time frame: Up to 4 years
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