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

N/ACompletedNCT01982500

Hellenic Oncology Research Group200 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Ovarian Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (6)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

"IASO" General Hospital of Athens

Athens, Greece

Air Forces Military Hospital of Athens

Athens, Greece

Outcomes

Primary Outcomes

Number of Participants with Adverse Events

In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks

Time frame: Every 3 weeks up to 18 weeks

Secondary Outcomes

Number of Participants with Response Rate

In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks

Time frame: Disease evaluation at Week 3

Percentage of Patients with Progression Free Survival

Time frame: 1 year

Patients Overall Survival

Time frame: 1 year

Data from ClinicalTrials.gov

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