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Rare Tumour Working Group. Active Trials. GOG 187 Phase 2 paclitaxel as 2 nd line therapy for ovarian stromal tumours-almost complete GOG239-Phase 2 AZD6244(MEK inhibitor) in recurrent low grade serous cancers recruiting well –target 50

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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


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GOG Proposed

  • GOG 241 MeOC Phase 3 carboplatin and paclitaxel +/- bevacizumabvs.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


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PARAGON

Phase 2 study of Aromatase inhibitors in women with potentially hormone Responsive recurrent/metastatic Gynaecological Neoplasms


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Background

  • Evidence that hormonal therapy is active in a subset of women with a wide range of gynaecological cancers

  • Response rates very variable- heterogeneous and unselected patients

  • Variety of agents- progestagens/tamoxifen/LHRH agonists

  • More recently evidence to support aromatase inhibitors


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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.


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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.


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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.


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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.


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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.



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