search
Back to results

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

Primary Purpose

Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

Status
Recruiting
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City Cancer Centre
  • Sir Gangaram Hospital
  • Batra Hospital & Medical Research Centre
  • Rajiv Gandhi Cancer Inst.&Research Center; Medical OncologyRecruiting
  • Apollo Hospitals International Ltd
  • Shalby Hospital LimitedRecruiting
  • Nirmal Hospital Pvt. Ltd.; Department of Oncology
  • Manipal Hospital; Department of Oncology
  • HealthCare Global Enterprises Limited; Medical OncologyRecruiting
  • HCG NMR Cancer Centre
  • Regional Cancer Centre; Dept of Oncology
  • Marthwada Regional Cancer Center & Research InstituteRecruiting
  • Mumbai Oncocare Center; Medical OncologyRecruiting
  • HCG NCHRI Cancer CenterRecruiting
  • HCG Manavata Cancer Centre
  • Curie Manavata Cancer Centre
  • Shatabdi Superspeciality Hospital
  • Apex Wellness Hospital
  • Sahyadri Speciality Hospital
  • Grant Medical Foundation, Ruby Hall Clinic
  • Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room
  • Fortis Malar Hospital
  • Apollo Speciality Hospital
  • Sri Ramchandra Medical Centre
  • Basavatarakam Indo-American Cancer Hospital & Research Institute
  • Apollo Gleneagles Hospitals
  • Peerless Hospitex Hospital and Research Center Ltd.Recruiting
  • MAX Balaji HospitalRecruiting
  • Bharat Cancer Hospital & Research Institute-Nirali Memorial Radiation Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events

Secondary Outcome Measures

Progression-free survival
Overall survival
Overall response rate (complete response + partial response)
Clinical benefit rate (complete response + partial response + stable disease)

Full Information

First Posted
August 27, 2013
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01932125
Brief Title
An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
up to approximately 1.5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
up to approximately 1.5 years
Title
Overall survival
Time Frame
up to approximately 1.5 years
Title
Overall response rate (complete response + partial response)
Time Frame
up to approximately 1.5 years
Title
Clinical benefit rate (complete response + partial response + stable disease)
Time Frame
up to approximately 1.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: ML28446 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global.rochegenentechtrials@roche.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City Cancer Centre
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Individual Site Status
Withdrawn
Facility Name
Sir Gangaram Hospital
City
NEW Delhi Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Withdrawn
Facility Name
Batra Hospital & Medical Research Centre
City
NEW Delhi Delhi
State/Province
Delhi
ZIP/Postal Code
110062
Country
India
Individual Site Status
Withdrawn
Facility Name
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Individual Site Status
Recruiting
Facility Name
Apollo Hospitals International Ltd
City
Ahemedabad
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Individual Site Status
Withdrawn
Facility Name
Shalby Hospital Limited
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Name
Nirmal Hospital Pvt. Ltd.; Department of Oncology
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Withdrawn
Facility Name
Manipal Hospital; Department of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Individual Site Status
Withdrawn
Facility Name
HealthCare Global Enterprises Limited; Medical Oncology
City
Banglore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Name
HCG NMR Cancer Centre
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580029
Country
India
Individual Site Status
Withdrawn
Facility Name
Regional Cancer Centre; Dept of Oncology
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Individual Site Status
Withdrawn
Facility Name
Marthwada Regional Cancer Center & Research Institute
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Individual Site Status
Recruiting
Facility Name
Mumbai Oncocare Center; Medical Oncology
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400056
Country
India
Individual Site Status
Recruiting
Facility Name
HCG NCHRI Cancer Center
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440026
Country
India
Individual Site Status
Recruiting
Facility Name
HCG Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Curie Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Individual Site Status
Withdrawn
Facility Name
Shatabdi Superspeciality Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Withdrawn
Facility Name
Apex Wellness Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422009
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Sahyadri Speciality Hospital
City
Pune City
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Grant Medical Foundation, Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Fortis Malar Hospital
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600020
Country
India
Individual Site Status
Withdrawn
Facility Name
Apollo Speciality Hospital
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600035
Country
India
Individual Site Status
Withdrawn
Facility Name
Sri Ramchandra Medical Centre
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600116
Country
India
Individual Site Status
Withdrawn
Facility Name
Basavatarakam Indo-American Cancer Hospital & Research Institute
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Individual Site Status
Withdrawn
Facility Name
Apollo Gleneagles Hospitals
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700054
Country
India
Individual Site Status
Withdrawn
Facility Name
Peerless Hospitex Hospital and Research Center Ltd.
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700094
Country
India
Individual Site Status
Recruiting
Facility Name
MAX Balaji Hospital
City
Delhi
ZIP/Postal Code
1100092
Country
India
Individual Site Status
Recruiting
Facility Name
Bharat Cancer Hospital & Research Institute-Nirali Memorial Radiation Centre
City
Gujarat
ZIP/Postal Code
395010
Country
India
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5825&EncHid=&userName=Bevacizumab
Description
Clinical Trials Registry - India

Learn more about this trial

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

We'll reach out to this number within 24 hrs