Study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological cancers
- Conditions
- Hormone responsive recurrent/metastatic gynaecological neoplasmsCancerMalignant neoplasms of female genital organs
- Registration Number
- ISRCTN43261139
- Lead Sponsor
- HS Greater Glasgow and Clyde (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 350
1. Patient with recurrent or metastatic gynaecological cancer. The specific subgroups are outlined below. All patients will have central review and analyses of oestrogen receptor/progesterone receptor (ER/PR) at a later date to confirm receptor status but entry to the study will be based on local hormone receptor analyses.
1.1. Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian fube
1.2. Endometrial cancer: patients that have measurable disease
1.3. Endometrial stromal sarcomas: patients that have measurable disease
1.4. Miscellaneous sarcomas: includes leimyosarcomas, adenosarcomas, carcinoasrcomas and undifferentiated sarcomas which have relapsed following standard treatment such as chemotherapy or patients in whom chemotherapy is not considered appropriate.
1.5. Granulosa cell tumours and other sex cord tumours: patients with measurable disease and/or elevated inhibin (total inhibin and/or inhibin B? level
1.6. UK centres will only enter patients to subgroups B-E of the study
2. 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 receptor positive, then these patients will be eligible.
3. Post menopausal as defined by:
3.1. Aged 60 or more, or
3.2. Age 45-59 and has amenorrhoea for at least 12 months and follicle-stimulating hormone (FSH) in postmenopausal range with an intact uterus, or having had a bilateral oophorectomy
4. Evaluable disease defined as
4.1. Measurable disease as per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1, or
4.2. Cancer antigen 125 (CA125) as per GCIG criteria (for ovarian cancer subgroup) or
4.3. Elevated total inhibin and/or inhibin B (for granulosa cell sub-group)
5. Eastern Cooperative Oncology Group (ECOG) peformance status 0-2
6. Expected survival > 3 months
Prior therapy with an aromatase inhibitor:
1. Patients receiving any hormone replacement therapy
2. Inability to comply with study procedures
3. Unable to give informed consent
4. 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
5. Significant hepatic (bilirubin >2xULN) or renal dysfunction (creatinine>3x ULN)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical benefit rate determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment. This will be determined radiologically by RECIST v1.1 or CA125 of inhibin (depending on the specific tumour type).
- Secondary Outcome Measures
Name Time Method <br> Progression free survival: this will be determined radiologically by Response Evaluation Criteria in Solid tumours (RECIST v1.1) or CA125 tumour marker response or inhibin.<br> 1. Response duration in each subgroup: this will be determined radiologically by RECIST v1.1 or CA125 or inhibin.<br> 2. Quality of life (QOL): will be assessed in the study using EORTC QLQ-C30 core questionnaire and the Functional Assessment of Cancer Therapy Endocrine Symptoms subscale.<br> 3.Toxicity :Proportion of patients experiencing grade 3 or 4 toxicities, adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.<br>