Transcript Rare Tumour Working Group

Rare Tumour Working Group
Active Trials
• GOG 187 Phase 2 paclitaxel as 2nd line therapy
for ovarian stromal tumours-almost complete
• GOG239-Phase 2 AZD6244(MEK inhibitor) in
recurrent low grade serous cancers recruiting
well –target 50
• GOG 251 Phase 2 bevacizumab in recurrent
sex cord stromal tumours- target 37
GOG Proposed
• GOG 241 MeOC Phase 3 carboplatin and
paclitaxel +/- bevacizumab vs.capecitabine and
oxaliplatin+/- bevacizumab as 1st line therapy in
mucinous ovarian cancers- aim 332 patients
• GOG 254 Phase 2 of sunitinib in clear cancers of
the ovary 37.5 mg daily
• RTM 602 Phase 2 of paclitaxel and carboplatin
vs.BEP in newly diagnosed advanced stage sex
cord stromal tumours
PARAGON
Phase 2 study of Aromatase inhibitors in
women with potentially hormone
Responsive recurrent/metastatic
Gynaecological Neoplasms
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Background
• Evidence that hormonal therapy is active in a
subset of women with a wide range of
gynaecological cancers
• Response rates very variableheterogeneous and unselected patients
• Variety of agentsprogestagens/tamoxifen/LHRH agonists
• More recently evidence to support
aromatase inhibitors
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Background
Difficult to investigate the role of hormonal
therapy, for uncommon subtypes of
gynaecological cancers, as there is a
disincentive to submit ethics applications and
open studies where the expectation is that
they might only recruit 1 or 2 patients a year.
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Background
• Single protocol and ethics application that
will encompass all eligible patients with
potentially hormone responsive recurrent
gynaecological cancers.
• This make to more attractive and easier for
all centres to participate.
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Aim
The aim of the study is to evaluate the activity of
anastrozole in women with recurrent or
metastatic potentially hormone responsive
gynaecological cancers
- epithelial ovarian cancer,
-sex cord stromal tumours of the ovary,
-endometrial cancer,
- endometrial sarcomas and miscellaneous
sarcomas.
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Primary objectives
•
•
•
•
•
•
Response to treatment by RECIST V1.1 criteria (all
tumor sub-groups) or CA125 tumour marker
response by Rustin criteria (ovarian sub-group) or
inhibin (granulosa cell sub-group)
Clinical benefit (complete response, partial
response and stable disease) in those with
measurable disease
Quality of life
Toxicity profile (including bone density).
Time to response
Response duration.
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Secondary Objectives
•
Translational sub-study. Correlate response
rates with hormone receptor positivity (Alldred
Histoscore) as well as other biological markers
such as ER subtypes α and β, EGFR, HER2,
vimentin, TFF1 and IGF that might predict for
hormone response.
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre
Study Schema
ANZGOG AGM, 2 April 2009, Noosa
NHMRC Clinical
Trials Centre