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Rare Tumour Working Group

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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Rare Tumour Working Group

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  1. Rare Tumour Working Group

  2. 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

  3. 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

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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Study Schema

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