platinum sensitive ovarian cancer patients progressing or recurring after a first-line treatment including bevacizumab. MedDRA version: 18.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: AVASTIN*INF 400MG 16ML 25MG/ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg milligram(s)
Conce
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 EOC, fallopian tube carcinoma or PC, including mixed Mullerian Tumours • Recurrence or progression at least 6 months after the last chemotherapy cycle of a first line carboplatin + paclitaxel chemotherapy including bevacizumab (recurrence or progression might occur either during or after bevacizumab as maintenance) • Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease • ECOG Performance Status of 0–2. • Life expectancy of ?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 including blood samples for molecular analyses. • Availability of tumour samples for molecular analyses from primary surgery (mandatory) and secondary surgery (when available) 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Ovarian tumours with low malignant potential (i.e. borderline tumours) • 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: The primary objective of this trial is to test whether the addition of bevacizumab to second-line chemotherapy can prolong progression-free survival (PFS) of platinum sensitive ovarian cancer patients progressing or recurring after a first-line treatment including bevacizumab.;Primary end point(s): PFS will be the primary end-point.;Timepoint(s) of evaluation of this end point: PFS will be measured from the date of randomization to the date of progression (defined by the investigator) or the date of death, whichever comes first.;Secondary Objective: Overall Survival (OS), response rate (RR), safety, as secondary end-points, will be also assessed. Exploratory objectives for this study are to assess the correlation of baseline plasma biomarker expression with clinical outcome, as measured by PFS and OS and to evaluate the association of other potential biomarkers, including, but not limited to, the single-nucleotide polymorphisms (SNPs), other potential plasma biomarkers, and tumor-specific markers as well as clinical factors with clinical outcome. Describing the prevalence of use of oral antidiabetic as well as antithrombotic drugs will also be considered as a secondary objective. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • OS will be measured from the date of randomization to the date of death • PFS defined by central independent review • ORR will be assessed according to RECIST version 1.1 • Identification of prognostic and predictive molecular factors;Timepoint(s) of evaluation of this end point: OS will be measured as the time between the randomisation and death for any cause of the patient. PFS as assessed by the central independent review, will be measured as the time between the randomisation and the progression (assessed by central independent review) or the death of the patient whichever occurs first | — |
Countries
France, Greece, Italy
Contacts
Public ContactProject leader
Arcagy-Gineco
Outcome results
None listed