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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria
Secondary Outcome
Time to Disease Progression
Condition
Recurrent Fallopian Tube Cancer
Intervention
cediranib maleate
Study Arms / Comparison Groups
Treatment (cediranib maleate)
Description: Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
74
Start Date
April 2006
Completion Date
January 15, 2018
Primary Completion Date
June 2010
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
Gender
Female
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Holger Hirte, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00278343
Organization ID
NCI-2012-03027
Secondary IDs
NCI-2012-03027
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Holger Hirte, Principal Investigator, Princess Margaret Hospital Phase 2 Consortium
Verification Date
July 2018