Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer MedDRA version: 16.1 Level: PT Classification code 10061344 Term: Peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classifica
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 =18 years of age with 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. 3. Patients must have platinum-resistant disease (defined as progression within =65 years) yes F.1.3.1 Number of subjects for this age range 133
Exclusion criteria
Exclusion criteria: 1. Patients whose disease was refractory to their previous platinum treatment. 2. Non-epithelial, including malignant mixed Müllerian tumours. 3. Ovarian tumours with low malignant potential. 4. History of other clinically active malignancy within 5 years of enrollment 5. Previous treatment with >2 anticancer regimens. 6. Any prior radiotherapy to the pelvis or abdomen. 7. Surgery (incl. open biopsy) within 4 wks 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 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: 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 >2.0mg/dl or >177µmol/l or calculated creatinine clearance 2+. Patients with =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 for those patients planned to receive paclitaxel. 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, hormonal or nonhormonal means of contraception (i.e. intrauterine contraceptive device) 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 CHF; serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia); peripheral vascular disease >grade 3. 24. LVEF defined by MUGA/ECHO below
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Disease progression, death, or 6 month after the first dose of study treatment, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR) • Overall survival (OS) ;Timepoint(s) of evaluation of this end point: For Objective response rate, the timepoint is disease progression, death, or 6 month after the first dose of study treatment, whichever occurs first. For overall survival, the timepoint is death or 12 month after the last patient last dose of study treatment, whichever occurs first | — |
Countries
Belgium, Bosnia and Herzegovina, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Turkey
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed