None listed
Conditions
Brief summary
There is compelling evidence to support a study of aromatase inhibitors in selected patients with potentially hormone sensitive recurrent or metastatic gynecological cancers. Hormonal therapy is an attractive option in patients with recurrent gynecological cancers where the objective of treatment is palliation and prolongation of survival rather than cure. Aromatase inhibitors are generally well tolerated and in contrast to chemotherapy can be administered for prolonged periods with relatively little cumulative toxicity. The degree of activity and response rates reported in previous studies has varied considerably. This variability almost certainly reflects the heterogeneous populations treated, which have included women with advanced chemotherapy and hormone resistant tumours and those with a poor performance status where response rates are generally low. There is a clear need to investigate the role of hormonal therapies, particularly AIs, in women with potentially hormone responsive recurrent gynaecological cancers. Studies are required to establish the response rates, clinical benefit and quality of life as well as to identify predictors of response.
Interventions
Registered patients are prescribed a 1mg Anastrazole (Armidex) tablet daily (orally) until disease progression
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
Prior therapy with an aromatase inhibitor, tamoxifen or progestagens Patients receiving any hormone replacement therapy Inability to comply with study procedures Unable to give informed consent Other active malignancy or primary malignancy diagnosed within the previous 5 years, except for treated squamous or basal cell carcinoma of skin or in situ cervical carcinoma Significant hepatic (bilirubin >2x ULN) or renal dysfunction (creatinine >3x ULN)
Outcome results
None listed