Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT01982500
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

Detailed Description

In the last decade, clinical studies with bevacizumab (Avastin) in various tumors have shown encouraging results in terms of efficacy/safety. However there is no data generated in Greek population with regards to safety and efficacy of bevacizumab in front line Ovarian Cancer. Two prior global phase III randomized trials showed that the addition of concurrent bevacizumab to standard chemotherapy and maintenance bevacizumab significantly increased the PFS in patients with advanced ovarian cancer It would be relevant to document the real life clinical data of bevacizumab in combination with chemotherapy (paclitaxel/carboplatin) in Front Line Ovarian Cancer as prescribed by the medical oncologists in Greece.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Primary Completion: 2016-10
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written informed consent
• Age ≥18 years
• Histologically confirmed advanced stage III (suboptimally debulked >1cm of residual disease) or stage IV ovarian cancer fallopian tube carcinoma or primary peritoneal cancer following surgical debulking with the aim of maximal surgical cytoreduction
• One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
• ECOG performance status ≤2
• Adequate haematological, renal and hepatic function
• Urine protein <2+ (dipstick)
• Life expectancy of >12 weeks

Exclusion Criteria

• Previous front line treatment for ovarina cancer
• Previous radiotherapy to target lesions
• Patients with brain metastases and/or cancerous meningitis
• Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
• Patients participating in interventional clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Every 3 weeks up to 18 weeks	In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients with Progression Free Survival	1 year
Number of Participants with Response Rate	Disease evaluation at Week 3	In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks
Patients Overall Survival	1 year

Trial Locations

Locations (6)

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athens; 🇬🇷 Athens, Greece