Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms
Conditions
Brief summary
This multicenter prospective 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. Data will be collected from eligible patients until death, withdrawal of consent, loss to follow-up, or study closure.
Interventions
DRUGBevacizumab
Participants will receive five cycles of bevacizumab 15 mg/kg concurrently with six cycles of the standard chemotherapy every three weeks (q3w), followed by extended cycles of bevacizumab 15 mg/kg q3w as a single agent for additional 16 cycles. A total of 21 cycles of bevacizumab will be administered in this study.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prescribed to receive bevacizumab or already ongoing on treatment with bevacizumab for advanced/metastatic ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to routine clinical practice
Exclusion criteria
* Not eligible for treatment with bevacizumab according to the local prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | up to approximately 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | up to approximately 1.5 years |
| Overall survival | up to approximately 1.5 years |
| Overall response rate (complete response + partial response) | up to approximately 1.5 years |
| Clinical benefit rate (complete response + partial response + stable disease) | up to approximately 1.5 years |
Countries
India
Outcome results
None listed