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

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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



- Determine the objective response rate (complete response, partial response, and stable
disease for ≥ 16 weeks) in patients with persistent, recurrent, or refractory advanced
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with


- Determine the time to disease progression, median survival time, and duration of
overall CA-125 antigen response in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
reaction to prior platinum-based regimen (sensitive vs insensitive).

Patients receive oral AZD2171 once daily for 4 weeks. Courses repeat every 4 weeks for up to
8 months in the absence of disease progression or toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.

Inclusion Criteria


- 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

- No known brain metastases


- 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

- 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

- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate (complete and partial response and stable disease) for ≥ 16 weeks as assessed by RECIST criteria

Safety Issue:


Principal Investigator

Hal W. Hirte, MD, FRCP(C)

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
City of Hope Comprehensive Cancer Center Duarte, California  91010