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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Recurrent Fallopian Tube Cancer

Recurrent Ovarian Epithelial Cancer

Recurrent Primary Peritoneal Cavity Cancer

Treatments

Other: laboratory biomarker analysis

Drug: cediranib maleate

Study type

Interventional

Funder types

NIH

Identifiers

NCT00278343

7129 (Other Identifier)

N01CM62209 (U.S. NIH Grant/Contract)

NCI-2012-03027 (Registry Identifier)

PMH-PHL-037

N01CM62201 (U.S. NIH Grant/Contract)

PHL-037 (Other Identifier)

NCI-7129

N01CM62203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

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