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

Brief Title

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

Official Title

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

Brief Summary

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

Detailed Description

      PRIMARY OBJECTIVES:

      I. Objective tumor response rate (complete plus partial response plus stable disease > 16
      weeks as defined by the Response Evaluation Criteria in Solid Tumors [RECIST] criteria) in
      women with recurrent or refractory advanced ovarian or primary peritoneal cancer.

      SECONDARY OBJECTIVES:

      I. Time to disease progression, median survival time, and duration of overall cancer antigen
      (CA)-125 response.

      OUTLINE:

      Patients receive cediranib maleate orally (PO) once daily (QD) every 4 weeks in the absence
      of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 4 weeks and then every 3
      months thereafter.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria

Secondary Outcome

 Time to Disease Progression

Condition

Recurrent Fallopian Tube Cancer

Intervention

cediranib maleate

Study Arms / Comparison Groups

 Treatment (cediranib maleate)

Description:  Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 2006

Completion Date

January 15, 2018

Primary Completion Date

June 2010

Eligibility 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 computed tomography (CT)
             scan OR patients must have evidence of progression based on an elevated CA-125
             (defined as a value of > 2 x upper limit of normal [ULN] documented on two separate
             determinations made > 2 weeks apart) if the physical exam is normal and CT scan of the
             chest/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

          -  Eastern Cooperative Oncology Group (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

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 × institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 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

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to AZD2171 (cediranib maleate)

          -  Mean corrected QT (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

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible

          -  Any significant abnormality noted in the electrocardiogram (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

Gender

Female

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Holger Hirte, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00278343

Organization ID

NCI-2012-03027

Secondary IDs

NCI-2012-03027

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Holger Hirte, Principal Investigator, Princess Margaret Hospital Phase 2 Consortium

Verification Date

July 2018