Study of preoperative everolimus in metastatic renal cell cancer
| ISRCTN | ISRCTN22979604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22979604 |
| EudraCT/CTIS number | 2009-013381-54 |
| Secondary identifying numbers | 10710 |
- Submission date
- 17/08/2011
- Registration date
- 17/08/2011
- Last edited
- 04/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Miss Amy Thomas
Scientific
Scientific
Fulham Road
London
SW3 6JJ
United Kingdom
| amy.thomas@rmh.nhs.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase II study of preoperative everolimus in metastatic renal cell cancer |
| Study acronym | E-PREDICT |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 18/06/2012 |
Eligibility
| 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 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 18/01/2010 |
| Date of final enrolment | 18/06/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
Royal Marsden NHS Foundation Trust (UK)
Research organisation
Research organisation
c/o Jane Lawrence
Assistant Director of Research and Development
Downs Road
Sutton
SM2 5PT
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Government
Seventh Framework Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Novartis Pharma AG (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
04/12/2017: No publications found, verifying study status with principal investigator
