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: Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer.; MedDRA version: 9.1Level: LLTClassification code 10033128; MedDRA version: 9.1Level: LLTClassification code 10016180; MedDRA version: 9.1Level: LLTClassification code 10061344

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-07
• Last Update Posted: 14 September 2015

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 patients awareness and willingness to comply with the study requirements. 2. Patients >= 18 years of age. 3. 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. 4. Patients must have platinum-resistant disease, (defined as progression within <6 months of platinum therapy) 5. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment. 6. ECOG PS 02. 7. Life expectancy of >= 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

Cancer-related 1. Patients whose disease was refractory to their previous treatment. Refractory disease is defined by those patients who progressed during the preceding treatment. 2. Non-epithelial, including malignant mixed M?llerian tumours. 3. Ovarian tumours with low malignant potential (i.e. borderline tumours). 4. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer Prior, current or planned treatment: 5. Previous treatment with >2 chemotherapy regimens. 6. Any prior radiotherapy to the pelvis or abdomen. 7. Surgery (including 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 the first study treatment. 9. Previous exposure to murine CA-125 antibody (only applicable to those patients with nonmeasurable disease by RECIST). 10. Current or recent (within 10 days prior to the first study drug dose) 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 (dose >10 mg/day methylprednisolone equivalent), excluding inhaled steroids. Laboratory: 13. Inadequate bone marrow function ANC: <1.5 x 109/l, or platelet count <100 x 109/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. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart). 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 &#956;mol/l or calculated creatinine clearance <40ml/min (by Cockroft & Gault formula) for patients intended to be treated with topotecan. urine dipstick for proteinuria >2+. Patients with &#8805; 2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate &#8804; 1 g of protein in the 24- hour urine. Alternatively, proteinuria testing can be performed according to local standards. Prior or concomitant conditions or procedures: 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 &#8805; 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). Et al.

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) - by RECIST and CA-125 response criteria (responders) - by RECIST only (RECIST responders) - by CA-125 response criteria only (CA-125 responders). Biological progression-free interval (PFIBIO) - by serum CA-125 and assessed according to the GCIG criteria Overall survival (OS) Quality of life (QOL) - QOL and symptom control will be assessed using EORTC QLQ-C30, QLQ-OV28, Hospital Anxiety Depression Scale (HADS), FACT/NCCN Ovarian Symptom Index (FOSI) and symptom questionnaires. 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.