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CompletedNCT00278343Updated Aug 29, 2018Results posted

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

A Phase 2 interventional study of cediranib maleate and laboratory biomarker analysis in Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer and Recurrent Primary Peritoneal Cavity Cancer, sponsored by National Cancer Institute (NCI). Completed at 28 sites in 2 countries. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
19 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
03

In context

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's enrollment of 74 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Treatment (cediranib maleate)

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

    Drug: cediranib maleate · Other: laboratory biomarker analysis

Interventions

  • Drugcediranib maleate

    30mg given PO, daily

    Also known as: AZD2171, Recentin

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

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

    Time frame: After 16 weeks

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0

    Time frame: Up to 4 years

07

Results

Posted Jul 2, 2017

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Cediranib Maleate)
Started74
Completed74
Not completed0

Outcome measures

PrimaryResponse 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
Reported as:
Number · participants
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria
participantsTreatment (Cediranib Maleate)
Platinum sensitive participants9
Platinum resistant participants0
SecondaryTime 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
Reported as:
Median · months
Time to Disease Progression
monthsTreatment (Cediranib Maleate)
Platinum Sensitive Participants7.2 (3.9 to 9.4)
Platinum Resistant Participants3.7 (3.4 to 4.5)
SecondaryOverall 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.
Reported as:
Median · months
Overall Survival (OS) (Discontinued as of 4/25/2014)
monthsTreatment (Cediranib Maleate)
Overall Survival (OS) (Discontinued as of 4/25/2014)18.9 (13.5 to 31.5)
SecondaryProgression-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
Reported as:
Median · months
Progression-free Survival (PFS)
monthsTreatment (Cediranib Maleate)
Progression-free Survival (PFS)4.9 (3.9 to 7)
SecondaryDuration 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
Reported as:
Number · weeks
Duration of Overall CA-125 Response
weeksTreatment (Cediranib Maleate)
Platinum sensitive participants108
SecondaryIncidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0
Time frame:
Up to 4 years

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Cediranib Maleate)—5/74 (6.8%)47/74 (63.5%)
Most frequent serious events
Most frequent serious events
EventTreatment (Cediranib Maleate)
Sinus tachycardiaCardiac disorders1/74
HypomagnesemiaMetabolism and nutrition disorders1/74
Death NOSGeneral disorders1/74
Alkaline phosphatase increasedInvestigations1/74
BruisingInjury, poisoning and procedural complications1/74
Most frequent other events
Most frequent other events
EventTreatment (Cediranib Maleate)
headacheNervous system disorders47/74
HypertensionVascular disorders18/74
fatigueGeneral disorders13/74
diarrheaGastrointestinal disorders7/74
Small intestinal obstructionGastrointestinal disorders4/74
Myocardial infarctionCardiac disorders2/74
Thromboembolic eventVascular disorders2/74

Baseline characteristics

Platinum sensitive: 39 Platinum resistant: 35 Total # treated: 74

Age, Categorical
Age, Categorical(Participants)Treatment (Cediranib Maleate)
<=18 years0
Between 18 and 65 years55
>=65 years19
Age, Continuous
Age, Continuous(years)Treatment (Cediranib Maleate)
Median58 (31 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Cediranib Maleate)
Female74
Male0
Region of Enrollment
Region of Enrollment(participants)Treatment (Cediranib Maleate)
Canada52
United States22
08

Study locations

28 sites
  • 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
    Saint 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
09

References and documents

Publications

  • 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. PubMed 25895616 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00278343
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 18, 2006
Start date
Apr 2006
Primary completion
Jun 2010
Completion
Jan 15, 2018
Results posted
Jul 2, 2017
Last update
Aug 29, 2018

Study contacts

Holger Hirte
principal investigator · Princess Margaret Hospital Phase 2 Consortium
View the source record on ClinicalTrials.gov ↗

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