Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Ovarian Cancer, Chemotherapy, Anti-angiogenic agent, Bevacizumab, Front Line
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
Status: Recruiting
Contact: Eva Maragkoudaki - +302810392570 - evamaragoud@gmail.com
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupolis, Greece
Status: Recruiting
Contact: Stylianos Kakolyris, MD
"IASO" General Hospital of Athens
Athens, Greece
Status: Recruiting
Contact: Stylianos Giassas, MD
Air Forces Military Hospital of Athens
Athens, Greece
Status: Recruiting
Contact: Nikos Fytrakis - 2107715690 - nikos251@yahoo.gr
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
Status: Recruiting
Contact: Nikolaos Ziras, MD
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Status: Recruiting
Contact: Ioannis Mpoukovinas, MD
Start Date
March 2012
Completion Date
March 2015
Sponsors
Hellenic Oncology Research Group
Source
Hellenic Oncology Research Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page