Condition category
Cancer
Date applied
17/08/2011
Date assigned
17/08/2011
Last edited
20/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Amy Thomas

ORCID ID

Contact details

Fulham Road
London
SW3 6JJ
United Kingdom
-
amy.thomas@rmh.nhs.uk

Additional identifiers

EudraCT number

2009-013381-54

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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Everolimus

Primary outcome measures

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 trial start date

18/01/2010

Overall trial end date

18/06/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

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

Federal/National Government

Location

Belgium

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes