The current standard treatment in patients with metastatic renal cancer includes nephrectomy followed by immune therapy with either interleukin 2 (rIL-2) or interferon (IFN-a). Unfortunately, responses occur in only approximately 15% of patients, with less than 5% benefiting from a durable remission. Treatment options for patients who progress on this treatment remain very limited. MedDRA version: 9.1 Level: LLT Classification code 10050018 Term: Renal cancer metastatic
Conditions
Interventions
Product Name: Sunitinib Malate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sutent-H-687-00-00
CAS Number: 557795-19-4
Concentration unit: mg milligram(s)
Concentration type: range
Concentr
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed renal cell carcinoma (clear cell) with measurable metastases on CT/ imaging.Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell, taken as part of the study. 2. Judged by the treating physician to have the potential to derive clinical benefit form sunitinib treatment 3. Male or Female, 18 years of age or older 4. Adequate organ function as defined by the following criteria: • Total serum bilirubin =2 x ULN (patients with Gilbert’s disease exempt) • Serum transaminases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable arrhythmia requiring medication. 2. Previous treatment for renal cancer. 3. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use adequate contraception during the period of therapy. The definition of effective contraception will be based on the judgement of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use adequate contraception. 5. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the effect of three months pre-operative treatment with SUNITINIB in patients with operable and inoperable metastatic renal cancer.;Secondary Objective: 1. To establish if there is a correlation between PET response and overall survival in these patients. Additionally changes in gene suppression 2. To investigate if changes in growth factor and growth factor receptor expression at a tissue level before and after treatment are associated response 3. Assess tumour response using sequential micro-array 4. To determine the proportion of patients that are deemed to be inoperable that will become operable with SU011248. 5. To evaluate the safety and tolerability profile ;Primary end point(s): The primary endpoint is time to radiological progression. | — |
Countries
United Kingdom
Outcome results
None listed