Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

AVASTIN

Study drug International non-proprietary name (INN) or common name

BEVACIZUMAB

Medical condition to be studied

Fallopian tube cancer
Ovarian epithelial cancer metastatic
Peritoneal carcinoma metastatic
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

100
Study design details

Main study objective

This multicenter prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Outcomes

To determine the safety profile (all grade 3 and above adverse events) of bevacizumab when added to standard chemotherapy (carboplatin and paclitaxel) in front line advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) in Indian population, Progression free survival (PFS)• Overall survival (OS)• Overall response rates (Complete response (CR)+ Partialresponse (PR)• Clinical benefit response rates (CR+PR+ Stable disease(SD)

Data analysis plan

All efforts will be made to regularly follow up patients to calculate Progression Free survival (PFS) and Overall Survival (OS).Kaplan-Meier procedure will be used to estimate the median PFS and OS for total as well as ECOG PS 0 and ECOG PS 1-2 at baseline. Log rank test will be used to compare the median survival time between subjects with ECOG PS 0 and ECOG PS 1-2 at baseline. The overall response rate (complete response CR + partial response PR) will be summarized using number and percentage along with two-sided 95% Pearson-Clopper confidence interval. Similarly, the Clinical Benefit Response rate (Complete Response + Partial Response + Stable Disease) will be summarized using number and percentage along with the twosided 95% Pearson-Clopper confidence interval.All statistical tests will be done at 5% level of significance.All patients with at least one follow up evaluation available wouldbe evaluated for efficacy.