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

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ClinicalTrials.gov Identifier: NCT01982500
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Ovarian Cancer

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.

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
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 Start Date : March 2012
Primary Completion Date : October 2016
Study Completion Date : July 2017


Groups and Cohorts

Group/Cohort
Avastin regimens
Patients who are going to receive chemotherapy plus Avastin (bevacizumab)


Outcome Measures

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


Secondary Outcome Measures :
  1. Number of Participants with Response Rate [ Time Frame: Disease evaluation at Week 3 ]
    In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks

  2. Percentage of Patients with Progression Free Survival [ Time Frame: 1 year ]
  3. Patients Overall Survival [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982500


Locations
Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, 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
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
Principal Investigator: Antonia Kalykaki, MD Hellenic Oncology Research Group
More Information

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01982500     History of Changes
Other Study ID Numbers: CT/12.01
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

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

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