EUCTR2012-004362-17-ITActive, not recruitingNot Applicable
A multicenter phase III randomized study with second line chemotherapy plus or minus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab/chemotherapy first line
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE 'G. PASCALE'0 sites400 target enrollmentStarted: December 21, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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
- •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:
- •ostage =Ia
- •ono more than superficial myometrial invasion
- •ono lymphovascular invasion
- •onot 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.
Investigators
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