A multi-centre, open-label, randomised, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer. - AURELIA

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

. Signed informed consent obtained prior to initiation of any study-specific
procedures and treatment as confirmation of the patient’s awareness and
willingness to comply with the study requirements.
. Patients =18 years of age
. Histologically confirmed and documented disease. The following histological types are eligible:
• adenocarcinoma NOS
• clear cell adenocarcinoma
• endometriod adenocarcinoma
• malignant Brenner's tumour
• mixed epithelial carcinoma
• mucinous adenocarcinoma
• serous adenocarcinoma
• transitional cell carcinoma
• undifferentiated carcinoma.
. Patients must have platinum-resistant disease, (defined as progression within <6
months of platinum therapy)
. Patients must have disease that is measurable according to RECIST or assessable
according to the GCIG CA-125 criteria and require chemotherapy treatment.
. ECOG PS 0–2.
. Life expectancy of greater than or equal to 12 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. Non-epithelial, including malignant mixed Müllerian tumours.
. Ovarian tumours with low malignant potential.
. Other malignancy within the last 5 years
. Minor surgical procedures within 24 hours prior to first study treatment.
. Previous exposure to murine CA-125 Ab (only applicable to those patients
with non-measurable disease by RECIST).
. Current or recent treatment with another investigational drug and/or
participation in another investigational study within 30 days of first study
treatment dosing or earlier participation in this study.
. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
. Inadequate bone marrow function: ANC: <1.5 x 10E9/l, or platelet count <100 x
10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain
haemoglobin values >9 g/dl.
. Inadequate coagulation parameters: aPTT >1.5 x ULN (patients on heparin
treatment must have an aPTT between 1.5 - 2.5 x ULN), or INR >1.5.
. Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the
institution; alkaline phosphatase, AST/SGOT or ALT/SGPT >2.5 x ULN (or 5 x ULN
in the presence of liver metastases).
. Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177
µmol/l or calculated creatinine clearance <40ml/min for patients intended to be
treated with topotecan. urine dipstick for proteinuria >2+. Patients with greater
than or equal to 2+ proteinuria on baseline dipstick analysis should undergo
a 24-hour urine collection and must demonstrate =1 g of protein in the 24-hour
urine. Alternatively, proteinuria testing can be performed according to local
standards.
. Pre-existing peripheral neuropathy =CTC grade 2.
. Pregnant or lactating females. Serum pregnancy test to be assessed within 7
days prior to study treatment start, or within 14 days (with a confirmatory urine
pregnancy test within 7 days prior to study treatment start).
. Women of childbearing potential not using highly-effective, non-hormonal means
of contraception (intrauterine contraceptive device or barrier method of
contraception in conjunction with spermicidal jelly) during the study and for 6
months after the last dose of study medication.
. LVEF defined by MUGA/ECHO below the institutional lower limit of normal (only
applicable for patients intended to be treated with PLD).
. Serious active infection requiring i.v. antibiotics and/or hospitalisation at study
entry.
. Known hypersensitivity to any of the study drugs or excipients.
. Evidence of any other medical conditions, physical examination or laboratory
findings that may interfere with the planned treatment, affect patient compliance
or place the patient at high risk from treatment-related complications.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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A study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with ovarian cancer.

F. Hoffmann-La Roche Ltd

Updated 8/4/2015