Neoadjuvant Therapy in Advanced Ovarian Cancer With Avastin
NOVA
A Randomized Phase II Multi-centric Open Label Clinical Trial to Determine the Efficacy and Toxicity of Preoperative Chemotherapy With or Without Bevacizumab in Patients With Advanced Ovarian Cancer
2 other identifiers
interventional
71
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2013
CompletedStudy Start
First participant enrolled
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2019
CompletedApril 1, 2020
May 1, 2019
2.1 years
April 26, 2013
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate
Complete response rate (microscopic residual tumor included) assessed by the surgeon at laparotomy after neoadjuvant therapy.
average 24 months
Secondary Outcomes (8)
Safety: toxicities and surgical complications
average 24 months
Surgical feasibility
average 24 months
Optimal surgery rate
average 24 months
RECIST 1.1 responses and correlation with serological responses (GCIG criteria)
average 24 months
Progression-free survival according RECIST 1.1 criteria
average 24 months
- +3 more secondary outcomes
Other Outcomes (2)
Histological response: comparison between the obtained response only with chemotherapy or chemotherapy and bevacizumab.
average 24 months
Association of clinical response with other potential biomarkers, including but not limited to, single nucleotide polymorphisms (SNP) and specific tumor markers.
Average 24 months
Study Arms (2)
Paclitaxel & Carboplatin
ACTIVE COMPARATOR1. 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.
Paclitaxel & Carboplatin & Bevacizumab
EXPERIMENTAL4 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.
Interventions
Eligibility Criteria
You may qualify if:
- Women over 18 years old
- Obtained informed consent, in writing and signed
- Histological confirmation of primary peritoneal carcinoma or fallopian tube carcinoma
- Planned interval debulking surgery
- ECOG:0 to 2
- Life expectancy \>12 weeks
You may not qualify if:
- Non-epithelial ovarian cancer, including malignant mixed Müllerian tumors.
- Borderline ovarian tumors.
- Administration of intraperitoneal chemotherapy planned.
- Previous systemic anti-tumor treatment against ovarian cancer.
- Intestinal obstruction or sub-occlusion, intestinal infiltration shown by CT scan or rectosigmoid infiltration in gynaecological examination.
- Uncontrolled hypertension.
- Any previous radiotherapy: abdomen or pelvis.
- Major traumatic injuries in the 4 weeks prior to the first potential dose of bevacizumab.
- History or clinical suspicion of brain metastases or spinal cord compression.
- History or evidence of central nervous system (CNS) disorders, unless properly treated with standard medical treatment.
- Cerebrovascular accident (CVA), transient ischemic attack (TIA) or subarachnoid haemorrhage (SAH) in the 6 months prior to randomization.
- Fertile women of childbearing age who are not willing to use effective contraception during the study and at least 6 months after the study.
- Women that are breastfeeding or pregnant.
- Prior exposure to mouse CA-125 antibody.
- Malignant tumors other than ovarian cancer within the 5 years prior to randomisation, with the exception of cervical carcinoma in situ treated correctly and/or basal-cell carcinoma.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Hospital La Fe
Valencia, Valencia, 46026, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
H. Reina Sofia
Córdoba, Spain
ICO Girona
Girona, Spain
ICO Hospitalet
Hospitalet Del Llobregat, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital Son Llatzer
Palma Mallorca, Spain
Parc Taulí
Sabadell, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yolanda García, MD
C.S Parc Taulí
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2013
First Posted
May 7, 2013
Study Start
May 6, 2013
Primary Completion
June 4, 2015
Study Completion
May 17, 2019
Last Updated
April 1, 2020
Record last verified: 2019-05