Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Miss Amy Thomas
ORCID ID
Contact details
Fulham Road
London
SW3 6JJ
United Kingdom
-
amy.thomas@rmh.nhs.uk
Additional identifiers
EudraCT/CTIS number
2009-013381-54
IRAS number
ClinicalTrials.gov number
Protocol/serial number
10710
Study information
Scientific title
A phase II study of preoperative everolimus in metastatic renal cell cancer
Acronym
E-PREDICT
Study hypothesis
Participants will be treated with everolimus 10mg orally daily for 6 weeks with repeat CT scanning, functional imaging and CTC/CEC sampling after 6 weeks. Cytoreductive nephrectomy will be carried out 1 week after stopping everolimus and molecular analyses carried out on the nephrectomy specimen. Everolimus will be continued post-operatively in all patients that derived benefit from pre-operative treatment
Ethics approval(s)
The Royal Marsden Research Ethics Committee-now the London-Chelsea REC, First MREC approval date 16/11/2009, ref: 09/h0801/96
Study design
Non-randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Renal Cancer; Disease: Kidney
Intervention
The sample size calculation is based on a Simon optimal two-stage design using a type I error level of 5% and power of 80%. We assume the treatment to be acceptable if less than 1% (P1=0.99) of patients experience non-haematological grade 4 toxicity or death due to the drug. If more than 10% (P0=0.90) of patients experience grade 4 non-haematological toxicity or death, the treatment is unacceptable.
Everolimus to be taken orally 10mg per day for 6 weeks prior to nephrectomy and then subsequent to nephrectomy until disease progression and following progression, if deriving clinical benefit.
Follow Up Length: 12 month(s); Study Entry : Registration only
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Everolimus
Primary outcome measure
Primary Outcome; Timepoint(s): safety of pre-operative and post-operative everolimus therapy in 19 evaluable patients
Secondary outcome measures
1. Efficacy [response rate (RR), progression-free survival (PFS), overall survival (OS)]
2. Toxicity (CTC)
3. Biomarkers (exploratory qualitative)
Overall study start date
18/01/2010
Overall study end date
18/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed metastatic renal cell carcinoma
2. At least one site of disease outside the kidney measurable per Response Evaluation Criteria In Solid Tumors (RECIST)
3. Scheduled to undergo nephrectomy as part of treatment plan
4. No prior systemic therapy for renal cell carcinoma
5. Male or female, 18 years of age or older
6. Life expectancy of 12 weeks or greater
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
8. Serum aspartate transaminase (AST) serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
9. Total serum bilirubin = 1.5 x ULN
10.Serum creatinine = 1.5 x ULN
11. Absolute neutrophil count (ANC) = 1.5 x109/L
12. Platelets = 100 x109/L
13. Haemoglobin = 9.0 g/dL
14. Prothrombin time (PT) = 1.5 x ULN
15. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment
16. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant exclusion criteria
1. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
2. Need for nephrectomy to relieve symptoms relating to the primary tumour or for emergency nephrectomy
3. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
5. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy
6. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to renal cell cancer (RCC)
Recruitment start date
18/01/2010
Recruitment end date
18/06/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Royal Marsden NHS Foundation Trust (UK)
Sponsor details
c/o Jane Lawrence
Assistant Director of Research and Development
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Funder name
Novartis Pharma AG (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|