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NCT01932125 Clinical Trial

An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

Ovarian Neoplasms Clinical Trial

Official title:
An Indian Multicentric, Open Label, Prospective Phase 4 Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer in Real-life Clinical Practice

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01932125
Other study ID # ML28446
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 5, 2018
Est. completion date June 21, 2025

Study information
Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 21, 2025
Est. primary completion date June 21, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bevacizumab
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.

Locations
Country Name City State
India Shalby Hospital Limited Ahmedabad Gujarat
India Marthwada Regional Cancer Center & Research Institute Aurangabad Maharashtra
India Manipal Hospital; Department of Oncology Bangalore Karnataka
India HealthCare Global Enterprises Limited; Medical Oncology Banglore Karnataka
India MAX Balaji Hospital Delhi
India Peerless Hospitex Hospital and Research Center Ltd. Kolkata WEST Bengal
India MOC Cancer Care & Research Centre Mumbai Maharashtra
India HCG NCHRI Cancer Center Nagpur Maharashtra
India Apex Wellness Hospital Nashik Maharashtra
India HCG Manavata Cancer Centre Nashik Maharashtra
India Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology New Delhi Delhi
India Grant Medical Foundation, Ruby Hall Clinic Pune Maharashtra
India Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room Pune Maharashtra
India Sahyadri Speciality Hospital Pune City Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: Incidence of adverse events up to approximately 1.5 years
Secondary Progression-free survival up to approximately 1.5 years
Secondary Overall survival up to approximately 1.5 years
Secondary Overall response rate (complete response + partial response) up to approximately 1.5 years
Secondary Clinical benefit rate (complete response + partial response + stable disease) up to approximately 1.5 years
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