CABARET
Trial status: CompletedProtocol title
Purpose of the study
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
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).
Study Chair
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
Publications
- Randomized phase 2 study of carboplatin and bevacizumab in recurrent glioblastoma. 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). https://dx.doi.org/10.1002/cncr.30838
- Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial https://doi.org/10.1111/ajco.12806
- Continuing or ceasing bevacizumab beyond progression in recurrent glioblastoma: an exploratory randomized phase II trial. 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. https://dx.doi.org/10.1016/j.jocn.2019.08
- HEALTH-RELATED QUALITY OF LIFE OUTCOMES FROM CABARET: A RANDOMIZED PHASE 2 TRIAL OF CARBOPLATIN AND BEVACIZUMAB IN RECURRENT GLIOBLASTOMA
- 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 http://dx.doi.org/10.1007/s11060-017-2479-8