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

NCT ID: NCT01932125

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2025-06-18

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Manipal Hospital

Bangalore, Karnataka, India

Site Status

HealthCare Global Enterprises Limited

Banglore, Karnataka, India

Site Status

Marthwada Regional Cancer Center & Research Institute

Aurangabad, Maharashtra, India

Site Status

MOC Cancer Care & Research Centre

Mumbai, Maharashtra, India

Site Status

HCG NCHRI Cancer Center

Nagpur, Maharashtra, India

Site Status

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Site Status

Apex Wellness Hospital

Nashik, Maharashtra, India

Site Status

Grant Medical Foundation, Ruby Hall Clinic

Pune, Maharashtra, India

Site Status

Jehangir Clinical Development Centre Pvt. Ltd

Pune, Maharashtra, India

Site Status

Sahyadri Speciality Hospital

Pune, Maharashtra, India

Site Status

Rajiv Gandhi Cancer Inst.&Research Center

New Delhi, National Capital Territory of Delhi, India

Site Status

Peerless Hospitex Hospital and Research Center Ltd.

Kolkata, West Bengal, India

Site Status

MAX Balaji Hospital

Delhi, , India

Site Status

Countries

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India

Related Links

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Other Identifiers

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ML28446

Identifier Type: -

Identifier Source: org_study_id

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