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

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.

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