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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982500
• Other study ID #: CT/12.01
• Status: Completed
• Phase: N/A
• First received: November 3, 2013
• Last updated: August 8, 2017
• Start date: March 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete
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

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks	Every 3 weeks up to 18 weeks
Secondary	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	Disease evaluation at Week 3
Secondary	Percentage of Patients with Progression Free Survival		1 year
Secondary	Patients Overall Survival		1 year