Clinical trial of first line treatment with carboplatin and paclitaxel plus bevacizumab for advanced ovarian cancer patients.

• Conditions: advanced ovarian cancer; MedDRA version: 15.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003043-29-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-14
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): overall toxicity;Timepoint(s) of evaluation of this end point: at the end of each cycle