Advanced Ovarian Cancer MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Grupo Español de Investigación en Cáncer de Ovario
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women over 18 years old 2. Obtained informed consent, in writing and signed 3. Histological confirmation, preferably by biopsy either by cytology with ovarian mass and a CA-125 >500 U/ml of epithelial ovarian carcinoma, primary peritoneal carcinoma or fallopian tube carcinoma 4. Planned interval debulking surgery 5. ECOG performance status of 0 to 2 6. Life expectancy >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 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: 1. Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours. 2. Borderline ovarian tumours (tumours of low malignant potential). 3. Administration of intraperitoneal chemotherapy planned. 4. Previous systemic anti-tumour treatment against ovarian cancer (for example, chemotherapy, monoclonal antibody therapy, treatment with tyrosine kinase inhibitors or hormonal treatment). 5. Intestinal obstruction or sub-occlusion, intestinal infiltration shown by CT scan or rectosigmoid infiltration in gynaecological examination. 6. Uncontrolled hypertension (defined as systolic pressure >150 mmHg and/or diastolic pressure >100mm maintained over time and despite antihypertensive treatment). 7. Any previous radiotherapy to the abdomen or pelvis. 8. Major traumatic injuries in the 4 weeks prior to the first potential dose of bevacizumab. 9. History or clinical suspicion of brain metastases or spinal cord compression. It is mandatory to perform a CT or MRI scan of the brain in cases of suspected brain metastases (in the 4 weeks prior to randomisation). It is also mandatory to perform an MRI scan of the spinal cord if compression of the spinal cord is suspected (in the 4 weeks prior to randomisation). 10. History or evidence, following a neurological examination, of central nervous system (CNS) disorders, unless properly treated with standard medical treatment, e.g. uncontrolled epileptic seizures. 11. Cerebrovascular accident (CVA), transient ischemic attack (TIA) or subarachnoid haemorrhage (SAH) in the 6 months prior to randomisation. 12. Fertile women of childbearing age who are not willing to use effective contraception (oral contraceptives, intrauterine device, barrier method with spermicidal gel or surgical sterilisation) during the study and at least 6 months after the study. 13. Women that are breastfeeding or pregnant. 14. Prior exposure to mouse CA-125 antibody. 15. Treatment with any other experimental product, or participation in another clinical trial within 30 days prior to inclusion. 16. Malignant tumours other than ovarian cancer within the 5 years prior to randomisation, with the exception of cervical carcinoma in situ treated correctly and/or basal-cell carcinoma. Patients may have received adjuvant chemotherapy for other tumours such as lung cancer or colorectal cancer, if diagnosed more than 5 years ago and with no evidence of recurrence. 17. Known hypersensitivity to bevacizumab or any of its excipients (including Cremophor). 18. Non-healing wound, active peptic ulcer or bone fracture. Patients with healing incised granulomas by secondary intention, with no evidence of fascial dehiscence or infection can be included, but they require three weeks of wound control. 19. History or evidence of bleeding or thrombotic diathesis. 20. Current or recent continued use of aspirin > 325 mg / day (within 10 days prior to randomization). 21. Current or recent use (within 10 days before the first cycle of treatment) of full doses of anticoagulants or thrombolytics administered orally or parenterally for therapeutic purposes (except for vascular permeability, in which case the INR should be kept below 1.5). 22. Clinically significant cardiovascular disease, including: Myocardial infarction or unstable angina (less or equal than 6 months before randomization); Congestive heart failure (CHF) class more or equal than II of the NYHA (New York Heart Association); Poor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Complete response rate (microscopic residual tumor included) assessed by the surgeon laparotomy after neoadjuvant therapy.;Secondary Objective: *Safety, toxicities and surgical complications *Surgical feasibility *Optimal surgery rate *RECIST 1.1 responses and correlation with serological responses *Progression-free survival *Correlation of high/low pre-and post-surgical plasma protein biomarker expression with clinical response. *Epithelial-mesenchymal transition performed at C.S. Parc Taulí;Primary end point(s): Complete response rate (microscopic residual tumor included) assessed by the surgeon laparotomy after neoadjuvant therapy.;Timepoint(s) of evaluation of this end point: Assessed by the surgeon laparotomy after neoadjuvant therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety, toxicity and complications 2. Surgical feasability 3. Optimal Surgery rate 4. Response according RECIST 1.1 and correlation with serological responses 5. Progression free survival 6. Correlation of expression of plasma protein biomarkers pre and post surgery with clinical response. 7. Epithelial-mesenchima transition performed at CS Parc Tauli 8. Descriptive of presence/absence of biomarkers and its correlation with treatment reponse and adverse reaction, performed at RCR.;Timepoint(s) of evaluation of this end point: 1. At each patient visit until end of treatment 2. Assessed after neoadjuvant treatment and before surgery. 3. After surgery. 4,5. At baseline, cycle 3, before cycle 5 (if suboptimal debulking, o residual disease), at the end of chemotherapy visit (Cycle 7), and every 12 weeks during Bevacizumab monotherapy. 6,7,8. Collection of biological samples in 10 different time points during clinical trial participation | — |
Countries
Spain
Contacts
Public ContactSecretaría Técnica GEICO
Secretaría GEICO
Outcome results
None listed