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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278343
First received: January 16, 2006
Last updated: June 9, 2014
Last verified: June 2014
  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. 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.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: cediranib maleate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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:
  • Efficacy of AZD2171 on response benefit (CR or PR or SD) based on the RECIST/Rustin criteria [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarise the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

  • Overall survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarise the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

  • Progression-free survival [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 months ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarise the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

  • Duration of overall CA-125 response [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarise the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.


Enrollment: 74
Study Start Date: April 2006
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cediranib maleate0
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.
Drug: cediranib maleate
Given orally
Other Names:
  • AZD2171
  • Recentin
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. The primary endpoint for this study will be objective tumour response rate (complete plus partial response plus stable disease >= 16 weeks as defined by the RECIST criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer.

II. The secondary endpoints for this trial include time to disease progression, median survival time, and duration of overall CA-125 response.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 CT scan OR patients must have evidence of progression based on an elevated CA-125 (defined as a value of >= 2 x ULN documented on two separate determinations made > 2 weeks apart) if the physical exam is normal and CT scan of the hest/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
  • 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
  • AST(SGOT)/ALT(SGPT) =< 2.5 × institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m2 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 because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
  • Mean 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
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Any significant abnormality noted in the 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278343

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Peoria Gynecologic Oncology
Peoria, Illinois, United States, 61603
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Health Sciences Centre-South Street
London, Ontario, Canada, N6A 4G5
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada, M5G 2M9
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Investigators
Principal Investigator: Holger Hirte Princess Margaret Hospital Phase 2 Consortium
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278343     History of Changes
Other Study ID Numbers: NCI-2012-03027, NCI-2012-03027, NCI-7129, PMH-PHL-037, PHL-037, 7129, N01CM62203, N01CM62209, N01CM62201
Study First Received: January 16, 2006
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014