A Phase 2 interventional study of Bevacizumab and Paclitaxel in Cancer, Ovarian, sponsored by Grupo Español de Investigación en Cáncer de Ovario. Terminated at 13 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-01.
Sponsored by Grupo Español de Investigación en Cáncer de Ovario · Phase 2, Interventional, and Treatment
Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.
Epithelial ovarian cancer (OC) is the fourth leading cause of cancer death in women, after lung, breast and colon cancer, and it represents the most common cause of death from gynaecological malignancies. The high mortality associated with OC is due to the lack of screening tests that enable an early diagnosis, thus the majority of patients are diagnosed at advanced stages of the disease when the chances of a cure are very limited. In fact, the 5-year overall survival (OS) rate for stage III-IV OC does not exceed 20-30% in many series. The standard treatment for advanced OC is maximal cytoreductive surgery (or debulking) followed by the administration of 6 cycles of adjuvant chemotherapy with carboplatin and paclitaxel.
In recent years, a number of studies have been carried out with antiangiogenic drugs. Specifically, bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be active both in monotherapy and combination therapy in patients with OC that have received multiple previous lines of chemotherapy.
One of the objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Grupo Español de Investigación en Cáncer de Ovario is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically significant cardiovascular disease, including:
Inadequate bone marrow function:
Inadequate coagulation parameters: Activated partial thromboplastin time (APTT) >1.5 x ULN or INR >1.5
Inadequate liver function, defined as:
Inadequate renal function, defined as:
1. Preoperative treatment Cycle 1 to 4 (4 cycles every 3 weeks of chemotherapy pre-surgery) * Carboplatin AUC 6 i.v. first day * Paclitaxel 175 mg/m2 i.v. first day 2. Surgery 3. Post-Operative treatment Cycle 5 to 7 (3 cycles every 3 weeks of chemotherapy post-surgery): * Carboplatin AUC 6 i.v. first day * Paclitaxel 175 mg/m2 i.v. first day * Bevacizumab 15 mg/Kg i.v. first day1 When the chemotherapy treatment is completed, the patient will continue with maintenance bevacizumab until 15 months length treatment.
Drug: Paclitaxel · Drug: Carboplatin
4 cycles every 3 weeks (at least 3 Bevacizumab neoadjuvant cycles): Carboplatin AUC 6 i.v. first day Paclitaxel 175 mg/m2 i.v. first day Bevacizumab 15 mg/Kg i.v. first day. b) Surgery Ovarian cancer surgery should be performed according to FIGO guidelines. c) Postoperative treatment Both arms: Cycle 5 to 7 (3 cycles every 3 weeks of chemotherapy post-surgery): Carboplatin AUC 6 i.v. first day Paclitaxel 175 mg/m2 i.v. first day Bevacizumab 15 mg/Kg i.v. first day. When the chemotherapy treatment is completed, the patient will continue with maintenance bevacizumab until 15 months length treatment.
Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin
Also known as: Avastin
Also known as: Taxol
Also known as: Paraplatin
Complete response rate
Complete response rate (microscopic residual tumor included) assessed by the surgeon at laparotomy after neoadjuvant therapy.
Time frame: average 24 months
Safety: toxicities and surgical complications
Safety and tolerability of the treatment will be assessed by adverse event description: incidence, severity, time of onset, causes, and abnormal laboratory values .
Time frame: average 24 months
Surgical feasibility
rate of patients in which surgery is feasible, comparing both arms.
Time frame: average 24 months
Optimal surgery rate
rate of patients in which surgery is optimal (residual disease\<1cm), comparing both arms
Time frame: average 24 months
RECIST 1.1 responses and correlation with serological responses (GCIG criteria)
It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables
Time frame: average 24 months
Progression-free survival according RECIST 1.1 criteria
tables of survival will be constructed by the Kaplan-Meier method. Mean and median, both with confidence intervals of 95%. Comparisons between groups will be made by log-rank test.
Time frame: average 24 months
Overall Survival (OS)
tables of survival will be constructed by the Kaplan-Meier method. Mean and median, both with confidence intervals of 95%. Comparisons between groups will be made by log-rank test.
Time frame: average 24 months
Association between clinical response and the expression of protein biomarkers, in pre-and post-surgical plasma.
It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables
Time frame: average 24 months
Biomarkers: Epithelial-mesenchymal transition performed at C.S. Parc Taulí
It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables
Time frame: average 24 months
Histological response: comparison between the obtained response only with chemotherapy or chemotherapy and bevacizumab.
information correlating the clinical laboratory with the response to treatment.
Time frame: average 24 months
Association of clinical response with other potential biomarkers, including but not limited to, single nucleotide polymorphisms (SNP) and specific tumor markers.
It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables
Time frame: Average 24 months
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Grupo Español de Investigación en Cáncer de Ovario