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

Primary Purpose

Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cediranib maleate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Fallopian Tube Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 × 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 Exclusion Criteria: 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

Sites / Locations

  • City of Hope
  • University of Southern California/Norris Cancer Center
  • City of Hope Medical Group Inc
  • University of California at Davis Cancer Center
  • University of Chicago
  • Decatur Memorial Hospital
  • Evanston Hospital CCOP
  • Ingalls Memorial Hospital
  • Joliet Oncology-Hematology Associates Limited
  • Loyola University Medical Center
  • Peoria Gynecologic Oncology
  • Oncology/Hematology Associates
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology Inc-Parkview
  • Northern Indiana Cancer Research Consortium
  • University of Maryland/Greenebaum Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • Oncology Care Associates PLLC
  • Saint John's Mercy Medical Center
  • University of Pittsburgh Cancer Institute
  • Medical College of Wisconsin
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • London Health Sciences Centre-South Street
  • London Regional Cancer Program
  • The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
  • University Health Network-Princess Margaret Hospital
  • CHUM - Hopital Notre-Dame

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cediranib maleate)

Arm Description

Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Duration of Overall CA-125 Response
Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.
Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0

Full Information

First Posted
January 16, 2006
Last Updated
July 31, 2018
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278343
Brief Title
Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
Official Title
A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (cediranib maleate)
Arm Type
Experimental
Arm Description
Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
cediranib maleate
Other Intervention Name(s)
AZD2171, Recentin
Intervention Description
30mg given PO, daily
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria
Description
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
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Description
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
Title
Overall Survival (OS) (Discontinued as of 4/25/2014)
Description
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.
Title
Progression-free Survival (PFS)
Description
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
Title
Duration of Overall CA-125 Response
Description
Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.
Time Frame
Up to 4 years
Title
Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0
Time Frame
Up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 × 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Hirte
Organizational Affiliation
Princess Margaret Hospital Phase 2 Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Southern California/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
City of Hope Medical Group Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California at Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Hospital CCOP
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Peoria Gynecologic Oncology
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Oncology/Hematology Associates
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
60702
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology Inc-Parkview
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46628
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States
Facility Name
Oncology Care Associates PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Saint John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Health Sciences Centre-South Street
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25895616
Citation
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.
Results Reference
derived

Learn more about this trial

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

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