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
8 other identifiers
interventional
74
2 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2006
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2006
CompletedFirst Posted
Study publicly available on registry
January 18, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2018
CompletedAugust 29, 2018
July 1, 2018
4.2 years
January 16, 2006
September 23, 2015
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
After 16 weeks
Secondary Outcomes (5)
Time to Disease Progression
Up to 4 years
Overall Survival (OS) (Discontinued as of 4/25/2014)
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)
Time from start of treatment to time of progression, assessed up to 6 months
Duration of Overall CA-125 Response
Up to 4 years
Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0
Up to 4 years
Study Arms (1)
Treatment (cediranib maleate)
EXPERIMENTALPatients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
30mg given PO, daily
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has recurred or is refractory to initial therapy; patients must have received platinum-based chemotherapy before entry into this protocol
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan OR patients must have evidence of progression based on an elevated CA-125 (defined as a value of \> 2 x upper limit of normal \[ULN\] documented on two separate determinations made \> 2 weeks apart) if the physical exam is normal and CT scan of the chest/abdomen/pelvis, has a disease volume \< 1 cm in maximum diameter
- Patients may have received no more than one prior chemotherapy regimen (i.e. initial first-line chemotherapy only)
- Life expectancy of greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 8 g/dL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 Ă— institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients with borderline tumors or tumors of low malignant potential
- Patients with current bowel obstruction
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
- Patients with known brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 (cediranib maleate)
- Mean corrected QT (QTc) \> 470 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with AZD2171
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Any significant abnormality noted in the electrocardiogram (ECG) within 14 days of treatment
- A New York Heart Association classification of III or IV (NOTE: patients classified as class II controlled with treatment may continue with increase monitoring)
- Conditions requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
City of Hope
Duarte, California, 91010, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, 90033, United States
City of Hope Medical Group Inc
Pasadena, California, 91105, United States
University of California at Davis Cancer Center
Sacramento, California, 95817, United States
University of Chicago
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Evanston Hospital CCOP
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Peoria Gynecologic Oncology
Peoria, Illinois, 61603, United States
Oncology/Hematology Associates
Peoria, Illinois, 61615-7828, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 60702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0944, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
London Health Sciences Centre-South Street
London, Ontario, N6A 4G5, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Related Publications (1)
Hirte H, Lheureux S, Fleming GF, Sugimoto A, Morgan R, Biagi J, Wang L, McGill S, Ivy SP, Oza AM. A phase 2 study of cediranib in recurrent or persistent ovarian, peritoneal or fallopian tube cancer: a trial of the Princess Margaret, Chicago and California Phase II Consortia. Gynecol Oncol. 2015 Jul;138(1):55-61. doi: 10.1016/j.ygyno.2015.04.009. Epub 2015 Apr 17.
PMID: 25895616DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hal Hirte
- Organization
- Juarvinski Cancer Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Holger Hirte
Princess Margaret Hospital Phase 2 Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2006
First Posted
January 18, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2010
Study Completion
January 15, 2018
Last Updated
August 29, 2018
Results First Posted
July 2, 2017
Record last verified: 2018-07