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

NCT ID: NCT00278343

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2018-01-15

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.

Conditions

Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (cediranib maleate)

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

Group Type: EXPERIMENTAL

cediranib maleate

Intervention Type: DRUG

30mg given PO, daily

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cediranib maleate

30mg given PO, daily

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD2171; Recentin

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Hirte

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital Phase 2 Consortium

Locations

City of Hope

Duarte, California, United States

University of Southern California/Norris Cancer Center

Los Angeles, California, United States

City of Hope Medical Group Inc

Pasadena, California, United States

University of California at Davis Cancer Center

Sacramento, California, United States

University of Chicago

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Evanston Hospital CCOP

Evanston, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Peoria Gynecologic Oncology

Peoria, Illinois, United States

Oncology/Hematology Associates

Peoria, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Oncology Care Associates PLLC

Saint Joseph, Michigan, United States

Saint John's Mercy Medical Center

St Louis, Missouri, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre-South Street

London, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus

Ottawa, Ontario, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

Countries

United States; Canada

References

Hirte H, Lheureux S, Fleming GF, Sugimoto A, Morgan R, Biagi J, Wang L, McGill S, Ivy SP, Oza AM. A phase 2 study of cediranib in recurrent or persistent ovarian, peritoneal or fallopian tube cancer: a trial of the Princess Margaret, Chicago and California Phase II Consortia. Gynecol Oncol. 2015 Jul;138(1):55-61. doi: 10.1016/j.ygyno.2015.04.009. Epub 2015 Apr 17.

Reference Type: DERIVED

PMID: 25895616 (View on PubMed)

Other Identifiers

NCI-2012-03027

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-7129

Identifier Type: -

Identifier Source: secondary_id

PMH-PHL-037

Identifier Type: -

Identifier Source: secondary_id

PHL-037

Identifier Type: OTHER

Identifier Source: secondary_id

7129

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62203

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-03027

Identifier Type: -

Identifier Source: org_study_id