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

NCT01982500 | Completed

• 1 other identifier: CT/12.01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Chemotherapy; Anti-angiogenic agent; Bevacizumab; Front Line

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants with Response Rate

  Disease evaluation at Week 3

• Percentage of Patients with Progression Free Survival

  1 year

• Patients Overall Survival

  1 year

Study Arms (1)

Avastin regimens

Patients who are going to receive chemotherapy plus Avastin (bevacizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinics for cancer prevention

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (6)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Antonia Kalykaki, MD

  Hellenic Oncology Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2013
• First Posted: November 13, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

GR (6)