Study of preoperative everolimus in metastatic renal cell cancer

• Register: ISRCTN
• Last refreshed on: 8 January 2018
• Main ID: ISRCTN22979604
• Date of registration: 17/08/2011
• Prospective Registration: No
• Primary sponsor: Royal Marsden NHS Foundation Trust (UK)
• Public title: Study of preoperative everolimus in metastatic renal cell cancer
• Scientific title: A phase II study of preoperative everolimus in metastatic renal cell cancer
• Date of first enrolment: 18/01/2010
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN22979604
• Study type: Interventional
• Study design: Non-randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Phase II

Countries of recruitment

United Kingdom

Contacts

• Name: Amy Thomas

Key inclusion & exclusion criteria

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
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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: National Cancer Research Network; Subtopic: Renal Cancer; Disease: Kidney
Cancer
Malignant neoplasm of kidney, except renal pelvis

Intervention(s)

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

Primary Outcome(s)

Primary Outcome; Timepoint(s): safety of pre-operative and post-operative everolimus therapy in 19 evaluable patients

Secondary Outcome(s)

1. Efficacy [response rate (RR), progression-free survival (PFS), overall survival (OS)]
2. Toxicity (CTC)
3. Biomarkers (exploratory qualitative)

Secondary ID(s)

10710

2009-013381-54

Source(s) of Monetary Support

Seventh Framework Programme, Novartis Pharma AG (UK)