AZD2171 in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278343
First received: January 16, 2006
Last updated: April 14, 2009
Last verified: January 2009
  Purpose

RATIONALE: AZD2171 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.

PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cediranib maleate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response rate (complete and partial response and stable disease) for ≥ 16 weeks as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Progression-free and overall survival at the median time-point and 6 months [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Duration of overall CA-125 antigen response [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2006
Estimated Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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 AZD2171.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278343

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Hal W. Hirte, MD, FRCP(C) Margaret and Charles Juravinski Cancer Centre
  More Information

Additional Information:
Publications:
Vidal L, Hirte H, Fleming GF, et al.: A phase 2 study of AZD2171 in recurrent or persistent ovarian, peritoneal or fallopian tube cancer: a study of the PMH, Chicago, and California phase II Consortia. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B2.

Responsible Party: Amit M. Oza, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00278343     History of Changes
Other Study ID Numbers: CDR0000456204, PMH-PHL-037, NCI-7129
Study First Received: January 16, 2006
Last Updated: April 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013