Please select the eligibility criteria that correspond to the clinical trial below.
Title: AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.


Options:
A: Inclusion Criteria:

* female patients, \>/=18 years of age
* epithelial ovarian, fallopian tube or primary peritoneal cancer
* platinum-resistant disease (disease progression within \<6 months of platinum therapy)
* EOCG performance status of 0-2

Exclusion Criteria:

* non-epithelial tumours
* ovarian tumours with low malignant potential
* previous treatment with \>2 chemotherapy regimens
* prior radiotherapy to the pelvis or abdomen
B: Inclusion Criteria:

* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
* Previous abdominal and/or pelvic external beam radiotherapy
* History of central nervous metastasis
* History of arterial or venous thromboembolism within 12 months prior to randomization
* Clinically significant cardiovascular disease within 12 months prior to randomization
C: Inclusion Criteria:

* Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
* Prior treatment with only 1 platinum based chemotherapy regimen
* Eastern Cooperative Oncology Group status of not more than 2
* Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion Criteria:

* Treatment with more than 1 prior chemotherapy regimen
* Progression within 6 months after starting initial chemotherapy
* Prior exposure to anthracyclines
* Unwilling or unable to have central venous catheter
* Known clinically relevant central nervous system metastasis
D: Inclusion Criteria:

* Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
* Treatment-free interval of \< 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
* Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
* Age \> 18 years.
* Life expectancy of at least 3 months.
* ECOG Performance Score \< 2.
* Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
* Adequate renal function: serum creatinine 1.5 x ULN.
* Absolute neutrophil count (ANC) \>1.5 x 109l, Platelets \> 100 x 109/l, Haemoglobin \> 9.0 g/dl.
* Written informed consent consistent with ICH-GCP guidelines.
* Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy \[HRT\]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Exclusion Criteria:

* Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
* Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
* Hypersensitivity to BIBF 1120 or the excipients of the study drug.
* Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure \> NYHA II).
* History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
* Patients who require full-dose anticoagulation.
* Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
* Brain metastases or leptomeningeal disease.
* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
* Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
* Patients unable to comply with the protocol.
* Active alcohol or drug abuse.
* Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
* Patients who are not clinically sterile.

Answer: A