Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms
- Conditions
- Women with oestrogen receptor and/or progesterone receptor positive (ER/PR+ve) potentially hormone responsive recurrent or metastatic gynaecological cancer including selected patients with epithelial ovarian cancer, endometrial cancers, miscellaneous sarcomas and sex cord stromal tumours of the ovaryTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2011-003192-11-BE
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- Not specified
*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 local hormone receptor analyses.
A.Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian tube.
*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 12weeks)
*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
*palinum 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 measureable disease
C.Endometrial stromal sarcomas: patients that have measureable disease
D.Miscellaneous Sarcomas: includes leiomyosarcomas, adenosarcomas, carcinosarcomas and undifferentiated uterine sarcomas which have relapsed following standard treatment such as chemotherapy or patients in whom chemotherapy is not considered appropriate
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
*All patients must have ER and/or PR positive tumours by immunohistochemical evaluation based on the assessment at individual sites. Hormone receptor staining shoul be carried out on the original tumour. If not availbale, but the recurrent tumour is receptor positive, then these patients will also be eligible.
*post-menopausal as defined by: age 60 or more, or age 45-59 and satisfying the following criteria: amenorrhoea for at least 12 months and FSH in postmenopausal range with an intact uterus, or having had a bilateral oophorectomy
*evaluable disease defined as: measurable disease as per RECIST v1.1 OR CA125 as per GCIG criteria (for ovarian cancer subgroup) or elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
*ECOG performance status 0-2
*Expected survival >3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
*prior therapy with an aromatase inhibitor
*patients receiving any hormone replacement therpay
*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 cervical carcinoma
*significant hepatic (bilirubin >2x ULN) or renal dysfunction (creatinine > 3x ULN)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: clinical benefit comprising either response or stable disease; Response as determined by Recist 1.1 in patients with measurable disease, CA125 in patients with ovarian cancer and no measurable disease and inhibin in patients with granulosa cell tumours with no measurable disease;Secondary Objective: * time to response in each sub-group<br>* response duration in each sub-group<br>* quality of life<br>* toxicity;Primary end point(s): * clinical benefit comprising either response or stable disease. Overall response rate as determined by RECIST v1.1 criteria (all tumour sub-groups) and/or CA125 tumour marker response by GCIG criteria (ovarian sub-group) or inhibin B/total inhibin (granulosa cell sub-group);Timepoint(s) of evaluation of this end point: * 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): *time to response in each sub-group<br>*response duration in each sub-group<br>*quality of life<br>*toxicity;Timepoint(s) of evaluation of this end point: *3 years