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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01982500
First received: November 3, 2013
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
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.

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Every 3 weeks up to 18 weeks ] [ Designated as safety issue: Yes ]
    In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks


Secondary Outcome Measures:
  • Number of Participants with Response Rate [ Time Frame: Disease evaluation at Week 3 ] [ Designated as safety issue: No ]
    In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks

  • Percentage of Patients with Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patients Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Avastin regimens
Patients who are going to receive chemotherapy plus Avastin (bevacizumab)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Clinics for cancer prevention

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982500

Contacts
Contact: Vassilis Georgoulias, MD +302810392750 georgulv@otenet.gr

Locations
Greece
University Hospital of Crete, Dep of Medical Oncology Recruiting
Heraklion, Crete, Greece
Contact: Eva Maragkoudaki    +302810392570    evamaragoud@gmail.com   
Principal Investigator: Antonia Kalykaki, MD         
University General Hospital of Alexandroupolis, Dept. of Medical Oncology Recruiting
Alexandroupolis, Greece
Contact: Stylianos Kakolyris, MD         
Contact: Nikolaos Xenidis, MD         
Principal Investigator: Stelios Kakolyris, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikos Fytrakis    2107715690    nikos251@yahoo.gr   
Principal Investigator: Nikos Kentepozidis, MD         
"IASO" General Hospital of Athens Recruiting
Athens, Greece
Contact: Stylianos Giassas, MD         
Principal Investigator: Stylianos Giassas, MD         
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Piraeus, Greece
Contact: Nikolaos Ziras, MD         
Principal Investigator: Nikolaos Ziras, MD         
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Ioannis Mpoukovinas, MD         
Principal Investigator: Ioannis Mpoukovinas, MD         
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
Principal Investigator: Antonia Kalykaki, MD Hellenic Oncology Research Group
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01982500     History of Changes
Other Study ID Numbers: CT/12.01
Study First Received: November 3, 2013
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Ovarian Cancer
Chemotherapy
Anti-angiogenic agent
Bevacizumab
Front Line

Additional relevant MeSH terms:
Genital Diseases, Female
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014