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

Completed · Phase 2

Conditions studied: Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

In brief

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.

Key facts

Study ID

NCT00278343

Run by

National Cancer Institute (NCI)

People needed

74

Starts

2006-04-01

Expected to finish

2018-01-15

Last updated by the study team

2018-08-29

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

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 × 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

Where it is running

• 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
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Evanston Hospital CCOP — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Peoria Gynecologic Oncology — Peoria, Illinois, United States
• Oncology/Hematology Associates — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Oncology Care Associates PLLC — Saint Joseph, Michigan, United States
• Saint John's Mercy Medical Center — St Louis, Missouri, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
• Cancer Centre of Southeastern Ontario at Kingston General Hospital — Kingston, Ontario, Canada
• London Health Sciences Centre-South Street — London, Ontario, Canada
• London Regional Cancer Program — London, Ontario, Canada

Full record on ClinicalTrials.gov

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