A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or
primary peritoneal cavity cancer

- Persistent, recurrent, or refractory to initial therapy

- Advanced disease

- Measurable or evaluable disease, as defined by 1 of the following:

- At least 1 lesion measured in at least 1 dimension as ≥ 20 mm with conventional
techniques or as ≥ 10 mm with spiral CT scan

- Evidence of progression based on an elevated CA-125 (defined as a value of ≥ 2
times upper limit of normal [ULN] documented on two separate determinations made
> 2 weeks apart) if the physical exam is normal and CT scan has a disease volume
< 1 cm in maximum diameter

- No borderline tumors or tumors of low malignant potential

- Patients must have received platinum-based chemotherapy prior to study entry

- No more than 1 prior chemotherapy regimen (i.e., initial first-line chemotherapy
only)

- No known brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2

- Karnofsky PS > 60-100%

- Life expectancy > 12 weeks

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8 g/dL

- Bilirubin normal

- ALT and AST ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No bowel obstruction

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to AZD2171

- Mean QTc ≤ 470 msec (with Bazett's correction)

- No history of familial long QT syndrome

- No psychiatric illness or social situation that would limit compliance with study
requirements

- No uncontrolled illness

- No HIV-positive patients on combination antiretroviral therapy

- No greater that +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week
apart

- No significant abnormality as seen by ECG within 14 days of treatment

- No New York Heart Associated class III or IV disease

- Class II disease controlled with treatment and increased monitoring is allowed

- No hypertension

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
radiotherapy, or major surgery

- No concurrent drugs or biologic agents with proarrhythmic potential

- No other investigational agents or participation in an investigational trial within
30 days prior to study entry

- No other concurrent anticancer agents or therapies