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

January 16, 2006
June 9, 2014
April 2006
June 2010   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00278343 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
AZD2171 in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Drug: cediranib maleate
    Given orally
    Other Names:
    • AZD2171
    • Recentin
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: cediranib maleate
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
74
Not Provided
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00278343
NCI-2012-03027, NCI-2012-03027, NCI-7129, PMH-PHL-037, PHL-037, 7129, N01CM62203, N01CM62209, N01CM62201
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Holger Hirte Princess Margaret Hospital Phase 2 Consortium
National Cancer Institute (NCI)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP