Clinical trial NCT01982500: Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer
Official title: A Multicentre, Observational Study of Bevacizumab (Avastin) Added to Front-line Chemotherapy in Patients With Stage IIIb, IIIC or IV Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma in Routine Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Chemotherapy
Anti-angiogenic agent
Bevacizumab
Front Line
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Clinics for cancer prevention

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Every 3 weeks up to 18 weeks
Secondary outcomes:
measure: Number of Participants with Response Rate
timeFrame: Disease evaluation at Week 3
measure: Percentage of Patients with Progression Free Survival
timeFrame: 1 year
measure: Patients Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: Hellenic Oncology Research Group
name: Antonia Kalykaki, MD
role: PRINCIPAL_INVESTIGATOR
References: