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E-PREDICT

A Phase II Study Of Preoperative Everolimus In Metastatic Renal Cell Cancer

Specialty
Cancer
Portfolio Eligibility
Adopted non-commercial study
ISRCTN 22979604
EudraCT 2009-013381-54
MREC N° 09/h0801/96
UKCRN ID 10710
WHO ID
Research Summary
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
Study Type Interventional
Design Type Treatment
Disease(s) Kidney
Phase II
Current Status Closed - in follow-up
Closure Date 11/19/2013
Global Sample Size 40
Global Recruitment to Date
  17%
Geographical Scope UK Multi-Centre
Lead Country England
Main Inclusion Criteria
1.Histologically confirmed metastatic renal cell carcinoma
2.At least one site of disease outside the kidney measurable per 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.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 enrollment
16.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Main 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 enrollment. 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 RCC
Chief Investigator(s)
Dr James Larkin
Further details, please contact
Miss Amy Thomas

Royal Marsden Hospital

Fulham Road
London
SW3 6JJ
UNITED KINGDOM

Tel: 02078082710
amy.thomas@rmh.nhs.uk
Funder(s) Novartis Pharma AG
FP7 European Commission health programme
Sponsor(s) The Royal Marsden Foundation Trust and Institute of Cancer Research




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