Study assessing the efficacy and the safety of bevacizumab in association with a standard chemotherapy before surgery of ovarian cancer

A RANDOMIZED, OPEN-LABEL, PHASE II STUDY ASSESSING THE EFFICACY AND THE SAFETY OF BEVACIZUMAB IN NEOADJUVANT THERAPY IN PATIENTS WITH FIGO STAGE IIIC/IV OVARIAN, TUBAL OR PERITONEAL ADENOCARCINOMA, INITIALLY UNRESECTABLE. - ANTHALYA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001144-22-FR

Enrollment

Unknown

Registered

2012-09-03

Start date

2012-07-03

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial ovarian cancer Fallopian tube carcinoma Primary peritoneal carcinoma MedDRA version: 20.0 Level: LLT Classification code 10052204 Term: Ovarian carcinosarcoma System Organ Class: 100000021045 MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10

Interventions

Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Current Sponsor code: RO4876646 Other descriptive name: rhuMAb V

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written, informed consent obtained prior to any study-specific procedure - Woman aged = 18 years - Histologically confirmed and documented, by peritoneal biopsy, high risk epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma - Patients are required to be deemed by a surgeron experienced in the management of ovarian cancer not to be eligible for primary complete debulking surgery during a laparoscopic procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Patient with: • non-epithelial ovarian cancer • ovarian tumour with low malignant potential (i.e. borderline tumour) • inadequate bone marrow, liver or renal function • Carcinosarcoma * Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy) * Planned intraperitoneal cytotoxic chemotherapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of neoadjuvant bevacizumab and chemotherapy measured by the complete resection rate after interval debulking surgery (IDS). Complete resection is defined as the removal of all macroscopic residual tumour at IDS (Completeness of Cytoreduction (CC) score = 0). ;Secondary Objective: * To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel neoadjuvant and adjuvant chemotherapy. * To assess the efficacy of bevacizumab measured by: • Objective Response Rate (ORR) assessed according to RECIST criteria (v 1.1) and/or CA-125 levels : - Before IDS (neoadjuvant phase) - After all courses of treatment (16 months following IDS) • Progression-free survival (PFS).;Primary end point(s): Complete resection is defined as the removal of all macroscopic residual tumour at IDS (CC score = 0) based on standardized operative report.;Timepoint(s) of evaluation of this end point: At the interval debulking surgery after the neo adjuvant therapy	—

Measure

Time frame

Main Objective: To evaluate the efficacy of neoadjuvant bevacizumab and chemotherapy measured by the complete resection rate after interval debulking surgery (IDS). Complete resection is defined as the removal of all macroscopic residual tumour at IDS (Completeness of Cytoreduction (CC) score = 0). ;Secondary Objective: * To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel neoadjuvant and adjuvant chemotherapy. * To assess the efficacy of bevacizumab measured by: • Objective Response Rate (ORR) assessed according to RECIST criteria (v 1.1) and/or CA-125 levels : - Before IDS (neoadjuvant phase) - After all courses of treatment (16 months following IDS) • Progression-free survival (PFS).;Primary end point(s): Complete resection is defined as the removal of all macroscopic residual tumour at IDS (CC score = 0) based on standardized operative report.;Timepoint(s) of evaluation of this end point: At the interval debulking surgery after the neo adjuvant therapy

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Secondary

Measure	Time frame
Secondary end point(s): - Efficacy : Objective Response Rate for the neoadjuvant period (defined from the baseline to IDS) and ORR after all courses of treatment will be assessed. Progression Free survival (PFS) will be assessed. Tumour assessments (based on RECIST V. 1.1 criteria) will include cross-sectional imaging (preferably by CT, or MRI in case of contrast allergy) of the pelvis and abdomen. Other modalities should be used as appropriate to ensure that adequately imaged and followed for signs of PD. Tumour assessments must be performed using the same imaging technique for a patient, throughout the trial. - Safety : Complete physical examination, measurement of vital signs, laboratory safety assessments according to local standards and recording of AEs according to the National Cancer Institute’s Cancer Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4 grades 1-5 will be performed by the investigator.;Timepoint(s) of evaluation of this end point: Efficacy : Tumour assessments will be performed at baseline, before IDS, before Cycle 8, then every 6 cycles (+/- 2 weeks of the scheduled visit) while the patient is receiving bevacizumab, at cessation of bevacizumab (+/- 4 weeks of the scheduled visit), every 6 months during follow-up, until disease progression . CA 125 will be performed at baseline, at each cycle before IDS, at IDS, before Cycle 5, at the end of Cycle 8, then every 6 cycles during treatment, at 28 days after end of treatment, every 6 months during follow-up, until disease progression - Safety : throughout the participation of the patient at this study	—

Measure

Time frame

Secondary end point(s): - Efficacy : Objective Response Rate for the neoadjuvant period (defined from the baseline to IDS) and ORR after all courses of treatment will be assessed. Progression Free survival (PFS) will be assessed. Tumour assessments (based on RECIST V. 1.1 criteria) will include cross-sectional imaging (preferably by CT, or MRI in case of contrast allergy) of the pelvis and abdomen. Other modalities should be used as appropriate to ensure that adequately imaged and followed for signs of PD. Tumour assessments must be performed using the same imaging technique for a patient, throughout the trial. - Safety : Complete physical examination, measurement of vital signs, laboratory safety assessments according to local standards and recording of AEs according to the National Cancer Institute’s Cancer Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4 grades 1-5 will be performed by the investigator.;Timepoint(s) of evaluation of this end point: Efficacy : Tumour assessments will be performed at baseline, before IDS, before Cycle 8, then every 6 cycles (+/- 2 weeks of the scheduled visit) while the patient is receiving bevacizumab, at cessation of bevacizumab (+/- 4 weeks of the scheduled visit), every 6 months during follow-up, until disease progression . CA 125 will be performed at baseline, at each cycle before IDS, at IDS, before Cycle 5, at the end of Cycle 8, then every 6 cycles during treatment, at 28 days after end of treatment, every 6 months during follow-up, until disease progression - Safety : throughout the participation of the patient at this study

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Countries

France

Contacts

Public ContactOpérations Cliniques/Direction Médi

ROCHE

essais.cliniques@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026