PARAGON- Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms: ANZGOG 0903 — ASN Events
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  3. PARAGON- Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms: ANZGOG 0903

PARAGON- Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms: ANZGOG 0903 (#330)

Linda Mileshkin 1 , Katrin M Sjoquist 2 , Dirkje w Sommeijer 3 , Dave Cannan 2 , Julie Martyn 2 , Kim Gillies 2 , Rachel O'Connell 2 , Val Gebski 2 , Peter Sykes 4 , Penny Blomfield 5 , Phillip Beale 6 , Michael Quinn 7 , Janine Lombard 8 , Alison Hadley 9 , Peter Grant 10 , Yoland Antill 11 , Martin Stockler 2 , Frederic Amant 12 , Richard J Edmondson 13 , Michael Friedlander 14
  1. Medical Oncology, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia
  2. NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
  3. Academic Medical Centre, Amsterdam, The Netherlands
  4. Christchurch Women's Hospital, Christchurch, New Zealand
  5. Royal Hobart Hospital, Hobart, Australia
  6. Royal Prince Alfred Hospital, Sydney, Australia
  7. Royal Women's Hospital, Melbourne, Australia
  8. Calvary Mater Newcastle, Newcastle, Australia
  9. Royal Brisbane and Women's Hospital, Brisbane, Australia
  10. Mercy Hospital for Women, Melbourne, Australia
  11. Frankston Medical Centre, Frankston, Australia
  12. UZ Gasthusisberg, Leuven, Belgium
  13. University of Manchester, Manchester, UK
  14. Royal Hospital for Women/Prince of Wales Hospital, Sydney, Australia

Background
Many gynaecological cancers of different pathological type express estrogen and/or progesterone hormone receptors (ER/PR). Reports of tumour response and clinical benefit with hormonal therapies exist showing variable rates of activity. There is a need to prospectively study the role of aromatase inhibitors in women with potentially hormone responsive recurrent gynaecological cancers to establish response rates, clinical benefit, quality of life (QoL), and identify predictors of response.
Methods
PARAGON is phase II Gynecologic Cancer InterGroup trial lead by the Australia New Zealand Gynaecological Oncology Group, Cancer Research UK and the Belgian Gynaecological Oncology Group. The study is designed to facilitate research in rare tumours. The protocol allows postmenopausal women with recurrent gynaecological cancers to enrol into one of 7 subgroups; epithelial ovarian cancer (EOC) with only rising CA125 after first line chemotherapy, platinum resistant/refractory EOC, low grade EOC, endometrial carcinomas, endometrial stromal sarcomas, miscellaneous sarcomas and granulosa cell tumours and other sex cord stromal tumours. ER/PR positivity must be confirmed by immunohistochemistry. Each subgroup will enrol 25-50 patients with defined stopping rules based on response and reviewed by independent data monitoring committee (IDMC).
Eligible patients receive 1 mg anastrozole daily until disease progression or unacceptable toxicity. Primary objective: clinical benefit (partial or complete response or stable disease). Secondary objectives: progression free survival, response duration, QoL, toxicity. Blood and tumour samples are being collected for translational studies and confirmation of ER/PR positivity.

ACTRN12610000796088

Recruitment commenced in 2011 in Australia, New Zealand and the United Kingdom. 260 of 350 planned patients have been enrolled to July 2014. Accrual to the platinum resistant/refractory and endometrial cancer subgroups closed on 9 December 2013 and 3 April 2014 respectively.

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