Metastatic Renal Cell Carcinoma
Conditions
Interventions
Trade Name: Votrient
Product Name: Pazopanib
Pharmaceutical Form: Tablet
INN or Proposed INN: PAZOPANIB HYDROCHLORIDE
CAS Number: 635702
Sponsors
Queen Mary university of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST). Only a component of clear cell is required. • No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions. • Adequate organ function as defined by the following criteria: i. Total serum bilirubin =1.5 x uln (patients with gilbert’s disease exempt) ii. Serum transaminases (ALT) 30ml/min iv. Absolute neutrophil count (ANC) =1000/mm3 without growth factor support v. Platelets = 75,000/mm3 • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment. • Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures • ECOG performance status of 0, 1 or 2. • 18 years or above (no upper age limit) • Male or female Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication. • Previous treatment for renal cancer • Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy. • Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy. • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart 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 • Prolonged QT interval >480msecs • Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease. • Bleeding diathesis • Current uncontrolled hypertension • Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical benefit of giving 14 weeks pazopanib to patients with metastatic kidney cancer prior to surgery to remove the cancerous kidney (nephrectomy). ; Secondary Objective: 1) To evaluate surgical complications (blood loss, post operative complications, hospital stay) 2) To evaluate the local response of the primary tumour to pazopanib 3) To evaluate progression free survival 4) To evaluate overall survival 5) To evaluate translational endpoints ;Primary end point(s): The primary outcome measure is to determine the proportion of patients who benefit clnically from 14 weeks of pre-operative pazopanib therapy. This will be assessed with CT scans. | — |
Countries
United Kingdom
Outcome results
None listed