Overview

This trial is active, not recruiting.

Condition ovarian cancer
Sponsor Hellenic Oncology Research Group
Start date March 2012
End date October 2016
Trial size 200 participants
Trial identifier NCT01982500, CT/12.01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Patients who are going to receive chemotherapy plus Avastin (bevacizumab)

Primary Outcomes

Measure
Number of Participants with Adverse Events
time frame: Every 3 weeks up to 18 weeks

Secondary Outcomes

Measure
Number of Participants with Response Rate
time frame: Disease evaluation at Week 3
Percentage of Patients with Progression Free Survival
time frame: 1 year
Patients Overall Survival
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Antonia Kalykaki, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hellenic Oncology Research Group.