Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

Inclusion Criteria14

• Patients with recurrent or metastatic gynaecological cancers. The specific subgroups are outlined below. All patients will have central review and analyses of ER/PR at a later date to confirm receptor status, but entry to the study will be based on hormone receptor positivity according to local hormone receptor analyses.
• A. Epithelial Ovarian Cancer, Primary Peritoneal Cancers and Cancers of the Fallopian Tube
• (i) Asymptomatic patients with a rising CA125 after first line chemotherapy and GCIG defined CA125 progression (these patients should either have no measureable disease or small volume recurrence and the expectation they would not require chemotherapy within the next 12 weeks)
• (ii) Borderline ovarian tumours, micro-invasive ovarian tumours and well differentiated low grade ovarian cancers. Apart from surgery, treatment options are very limited for these patients as these tumours are usually chemotherapy resistant but are also relatively indolent
• (iii) Platinum resistant or refractory ovarian, fallopian tube and primary peritoneal cancer in patients in whom further chemotherapy is not indicated
• B. Endometrial Cancer – patients that have measurable disease
• C. Endometrial Stromal Sarcomas: patients that have measurable disease
• D. Miscellaneous Sarcomas: Includes leiomyosarcomas, adenosarcomas, carcinosarcomas and undifferentiated uterine sarcomas with measurable disease and relapse following standard treatment such as chemotherapy or patients in whom chemotherapy is not clinically indicated.
• E. Granulosa Cell Tumours and other Sex Cord Stromal Tumours: patients that have measurable disease and/or an elevated inhibin (total inhibin and/or inhibin B) level and in whom chemotherapy is not clinically indicated
• All patients must have ER and/or PR positive tumours by immunohistochemical evaluation based on the assessment at individual sites. Hormone receptor staining should be carried out on the original tumour. If not available, but the recurrent tumour is hormone receptor positive, then these patients will also be eligible
• Post-menopausal as defined by: (i) age 60 or more, or (ii) age 45–59 and satisfying the following criteria: Amenorrhoea for at least 12 months and FSH in postmenopausal range with an intact uterus, or (iii) age equal to 18 or more and having had a bilateral oophorectomy
• Evaluable disease defined as; (i) measurable disease as per RECIST v1.1, OR (ii) CA125 as per GCIG criteria (for ovarian cancer subgroup) OR (iii) elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
• ECOG Performance status 0-2
• Expected survival > 3months