Ensayo fase III multicéntrico, abierto, aleatorizado, de dos brazos, de bevacizumab más quimioterapia versus quimioterapia sola para el tratamiento de pacientes con cáncer de ovario epitelial, de trompa de Falopio o peritoneal primario, resistente a platinos. 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

• Conditions: Cáncer de ovario epitelial, de trompa de Falopio o peritoneal primario, resistente a platinos.Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer; MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer; MedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancer; MedDRA version: 9.1Level: LLTClassification code 10061344Term: Peritoneal neoplasm

• Registration Number: EUCTR2009-011400-33-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-01
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. 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.
2. Patients greater than or equal to 18 years of age with histologically confirmed and
documented. 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.
3. Patients must have platinum-resistant disease, (defined as progression within <6
months of platinum therapy)
4. Patients must have disease that is measurable according to RECIST or assessable
according to the GCIG CA-125 criteria and require chemotherapy treatment.
5. ECOG PS 0?2.
6. 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

1. Patients whose disease was refractory to their previous treatment.
2. Non-epithelial, including malignant mixed Müllerian tumours.
3. Ovarian tumours with low malignant potential.
4. Other malignancy within the last 5 years
5. Previous treatment with >2 chemotherapy regimens.
6. Any prior radiotherapy to the pelvis or abdomen.
7. Surgery (incl. open biopsy) within 4 weeks prior to the start of study, or
anticipation of the need for major surgery during study treatment.
8. Minor surgical procedures within 24 hours prior to first study treatment.
9. Previous exposure to murine CA-125 Ab (only applicable to those patients
with non-measurable disease by RECIST).
10. Current or recent chronic daily treatment with aspirin (>325 mg/day).
11. 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.
12. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
13. 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.
14. 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.
15. 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).
16. 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.
17. History or evidence upon physical/neurological examination of CNS disease
unrelated to cancer, unless adequately treated with standard medical therapy
(e.g. uncontrolled seizures).
18. Symptomatic CNS metastasis
19. Pre-existing peripheral neuropathy ?CTC grade 2.
20. 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).
21. 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.
22. History or evidence of thrombotic or hemorrhagic disorders; including CVA/
stroke or TIA or sub-arachnoid haemorrhage within ?6 months prior to the first
study treatment.
23. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100
mmHg despite antihypertensive therapy) or clinically significant (i.e. active)
cardiovascular disease, including: myocardial infarction or unstable angina within
?6 months prior to the first study treatment; NYHA grade II or greater

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare progression-free survival (PFS) of patients randomised to selected chemotherapy only or to selected chemotherapy plus bevacizumab;Secondary Objective: ? Objective response rate (ORR)<br>- by RECIST and CA-125 response criteria (?responders?)<br>- by RECIST only (?RECIST responders?)<br>- by CA-125 response criteria only (?CA-125 responders?). <br>? Biological progression-free interval (PFIBIO)<br>- by serum CA-125 and assessed according to the GCIG criteria<br>? Overall survival (OS)<br>? Quality of life (QOL)<br>- QOL and symptom control will be assessed using EORTC QLQ-C30, QLQ-OV28, <br> Hospital Anxiety Depression Scale (HADS), FACT/NCCN Ovarian Symptom Index <br> (FOSI) and symptom questionnaires.<br>? Safety and tolerability;Primary end point(s): The primary efficacy variable is progression-free survival (PFS). It is defined as the time from the date of randomisation to the first documented disease progression or death, whichever occurs first. <br>.