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CABARET

Summary

In this Phase II trial, patients with recurrent glioblastoma receive either bevacizumab alone or in combination with carboplatin until progression, then are re-randomised to continue or cease bevacizumab alongside alternative chemotherapy or supportive care. MRI scans, neurological exams, and steroid use are assessed at baseline and regular intervals (every 4–8 weeks), with secondary measures including cognitive function (MMSE, Cogstate), quality of life (EORTC QLQ-C30, QLQ-BN20, EQ-5D), corticosteroid dose, and toxicity (CTCAE v4.0) collected at screening, throughout treatment, and during follow-up

Study Chair

Associate Professor Kathryn Field

Coordinating Centre

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: cabaret.study@sydney.edu.au

Design

Phase II, multi-centre, randomized, open-label

Cancer Type

Glioblastoma

Intervention

Part 1 – Bevacizumab plus carboplatin versus bevacizumab alone.
Arm A: Bevacizumab 10mg/kg given intravenously (IV) every 2 weeks until disease progression
Arm B: Bevacizumab 10mg/kg given intravenously (IV) every 2 weeks + carboplatin AUC 5 given IV every 4 weeks until disease progression

Part 2 – Effects of continuing or stopping bevacizumab after disease progression.

Following disease progression in Part 1 patients who are able and who consent to continue onto Part 2 of the study will receive further treatment as follows:

Patients who were in Arm A of the study will commence carboplatin chemotherapy AUC 5 IV every 4 weeks until disease progression. If a patient decides with their doctor that they are not suitable for further chemotherapy, they will receive best supportive care rather than carboplatin. Best supportive care involves treatments to assist with controlling the symptoms of cancer such as antibiotics and pain medication. Patients will then be randomised to cease bevacizumab (Arm C) or continue bevacizumab 10mg/kg, 2 weekly until disease progression (Arm D).

Patients who were in Arm B of the study will cease carboplatin and choose between two chemotherapy agents (temozolomide or etoposide) in consultation with their doctor. As above, patients who are not suitable for additional chemotherapy may elect to receive best supportive care rather than etoposide or temozolomide. Patients will then be randomised to cease bevacizumab (Arm E) or continue bevacizumab 10mg/kg, 2 weekly until disease progression (Arm F).

Publications

Randomized phase 2 study of carboplatin and bevacizumab in recurrent glioblastoma. K. Field, J. Simes, E. Hovey, A. Nowak, L. Cher, H. Wheeler, C. Brown, E. Barnes, K. Sawkins, A. Livingstone, M. Rosenthal, P. Phal, G. Fitt, C. Goh, M. Tattersall, P. Kelly, A. Hayden, K. Sawkins, C. Brown, L. Barnes, A. Livingstone, D. Winter, B. Tomes, R. Pike, J. Simes, R. Freilich, I. Arzhintar, K. Field, M. Rosenthal, L. Garrett, J. Simes, A. Byrne, A. Dowling, N. Ranieri, R. Jennens, F. Osmond, W.K. Patterson, A. Phay, F. Abell, L. Plowman, L. Cher, J. Flynn, E. Hovey, H. Kilsby, H. Wheeler, S. Kirby-Lewis, N. Singhal, S. Smith, M. Whelan, P. Inglis, A. Ives, A. Nowak, S. Lobb, S. Begbie, P. Williams, Z. Lwin, N. Woodward, G. Crosbie, R. Harrup, L. Pyszkowski, S. Gauden, A. Neville
https://dx.doi.org/10.1093/neuonc/nov104

The role of early magnetic resonance imaging in predicting survival on bevacizumab for recurrent glioblastoma: Results from a prospective clinical trial (CABARET). Kathryn M. Field,Greg Fitt, Christine Goh,Anna K. Nowak, Mark A. Rosenthal, John Simes, Elizabeth H. Barnes, Kate Sawkins, Lawrence M. Cher, Elizabeth J. Hovey, Helen Wheeler. https://dx.doi.org/10.1002/cncr.30838

Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial. Kathryn M. Field, Greg Fitt, Mark A. Rosenthal, John Simes, Anna K. Nowak, Elizabeth H. Barnes, Kate Sawkins, Christine Goh, Bradford A. Moffat, Simon Salinas, Lawrence Cher, Helen Wheeler, Elizabeth J. Hovey, Pramit M. Phal. https://doi.org/10.1111/ajco.12806

Continuing or ceasing bevacizumab beyond progression in recurrent glioblastoma: an exploratory randomized phase II trial. Elizabeth J Hovey , Kathryn M Field , Mark A Rosenthal , Elizabeth H Barnes , Lawrence Cher , Anna K Nowak , Helen Wheeler , Kate Sawkins , Ann Livingstone , Pramit Phal , Christine Goh , John Simes , on behalf of CABARET/COGNO investigators. https://doi.org/10.1093/nop/npw025

Whole genome and biomarker analysis of patients with recurrent glioblastoma on bevacizumab: A subset analysis of the CABARET trial. Lauren R. Olafsona, Anna H. Siddella, Kathryn M. Fieldb, Madeleine Byrnesa, Robert W. Rapkinsa, Benedict Nga, Sheri Nixdorfa, Elizabeth H. Barnesd,Terrance G. Johnse, Sonia Yip, John Simes,Anna K. Nowak, Mark A. Rosenthalb,Kerrie L. McDonaldad. https://dx.doi.org/10.1016/j.jocn.2019.08.
EARLY PERFUSION MRI PREDICTS SURVIVAL OUTCOME IN PATIENTS WITH RECURRENT GLIOBLASTOMA TREATED WITH BEVACIZUMAB AND CARBOPLATIN.
Bennett IE, Field KM, Hovens CM, Moffat BA, Rosenthal MA, Drummond K, Kaye AH, Morokoff AP.
Journal of Neuro-Oncology. 2016. Volume 131, pages 321–329.
Published online 28 November 2016. Article available on https://doi.org/10.1007/s11060-016-2300-0

HEALTH-RELATED QUALITY OF LIFE OUTCOMES FROM CABARET: A RANDOMIZED PHASE 2 TRIAL OF CARBOPLATIN AND BEVACIZUMAB IN RECURRENT GLIOBLASTOMA
Kathryn M. Field, Madeleine T. King, John Simes, David Espinoza, Elizabeth H. Barnes, Kate Sawkins, Mark A. Rosenthal, Lawrence Cher, Elizabeth Hovey, Helen Wheeler, Anna K. Nowak.

Journal of Neuro-Oncology. Volume 133, pages 623–631, (2017).

Published online 22 May 2017.

Article available on http://dx.doi.org/10.1007/s11060-017-2479-8

Date of activation:

Expected final accrual date:

Purpose of the study

ELIGIBILITY CRITERIA

Inclusion Criteria

Exclusion Criteria

Patient population

Primary outcome

Intervention

Part 1 – Bevacizumab plus carboplatin versus bevacizumab alone.
Arm A: Bevacizumab 10mg/kg given intravenously (IV) every 2 weeks until disease progression
Arm B: Bevacizumab 10mg/kg given intravenously (IV) every 2 weeks + carboplatin AUC 5 given IV every 4 weeks until disease progression

Part 2 – Effects of continuing or stopping bevacizumab after disease progression.

Following disease progression in Part 1 patients who are able and who consent to continue onto Part 2 of the study will receive further treatment as follows:

Patients who were in Arm A of the study will commence carboplatin chemotherapy AUC 5 IV every 4 weeks until disease progression. If a patient decides with their doctor that they are not suitable for further chemotherapy, they will receive best supportive care rather than carboplatin. Best supportive care involves treatments to assist with controlling the symptoms of cancer such as antibiotics and pain medication. Patients will then be randomised to cease bevacizumab (Arm C) or continue bevacizumab 10mg/kg, 2 weekly until disease progression (Arm D).

Patients who were in Arm B of the study will cease carboplatin and choose between two chemotherapy agents (temozolomide or etoposide) in consultation with their doctor. As above, patients who are not suitable for additional chemotherapy may elect to receive best supportive care rather than etoposide or temozolomide. Patients will then be randomised to cease bevacizumab (Arm E) or continue bevacizumab 10mg/kg, 2 weekly until disease progression (Arm F).

Secondary outcome

17 Participating Sites

122 Recruitment Target

Additional Information
Contact Email

Trial Locations

VIC

Location:

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia

Trials & Research

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