advanced ovarian cancer MedDRA version: 15.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: NA
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female patients =18 years of age. • Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone. • FIGO stage IIIB & C or IV • ECOG Performance Status of 0–2. • Life expectancy of at least 12 weeks. • 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. • Availability of tumour samples for molecular analyses Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Ovarian tumours with low malignant potential (i.e. borderline tumours) • Previous systemic anti-cancer therapy for advanced ovarian cancer. • History or evidence of brain metastases or spinal cord compression. • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: o stage =Ia o no more than superficial myometrial invasion o no lymphovascular invasion o not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To explore whether clinical and biological factors, as detailed below, are able to identify a subset of patients with better prognosis in term of progression free survival (PFS) and overall survival (OS) after combined therapy with chemotherapy and bevacizumab.;Secondary Objective: • To describe the safety of bevacizumab added to carboplatin-paclitaxel chemotherapy in first line treatment of epithelial ovarian, fallopian tube and primary peritoneal cancer patients in the clinical routine practice • To investigate the prognostic value for hypertension, circulating and in-situ biomarkers for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer patients treated with carboplatin-paclitaxel and bevacizumab • To describe the prevalence of use of oral antidiabetic therapy and antithrombotic therapy among the patients enrolled in the trial.;Primary end point(s): PFS and OS;Timepoint(s) of evaluation of this end point: at disease progression or patient death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): overall toxicity;Timepoint(s) of evaluation of this end point: at the end of each cycle | — |
Countries
Italy
Contacts
Public ContactUnità Sperimentazioni Cliniche
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE
Outcome results
None listed