Metastatic Renal Cell Carcinoma MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib
CAS Number: 341031-54-7
Current Sponsor code: Suni
Sponsors
The Royal Marsden NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with advanced renal cell carcinoma suitable for 1st line therapy with sunitinib 2. Histologically or cytologically confirmed advanced renal cell carcinoma 3. The presence of one or more clinically or radiographically measurable lesions 4. ECOG performance status 0 or 1 5. Life expectancy greater than 12 weeks 6. At least 14 days since major surgery and 7 days since skin/tumour biopsy 7. The capacity to understand the patient information sheet and the ability to provide written informed consent 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures 9. Male or female, age 18 or greater 10. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilized). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment 11. Serum aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 x upper limit of normal (ULN) 12. Total serum bilirubin =1.5 x ULN 13. Serum creatinine =1.5 x ULN 14. Haemoglobin =9.0 g/dL 15. Absolute neutrophil count =1.5 x 109/L 16. Platelets =100 x 109/L 17. Prothrombin time (PT) =1.5 x ULN 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: 1. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC 2. 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 3. Previous systemic treatment for metastatic renal cell carcinoma. Palliative radiotherapy to symptomatic disease sites is permitted 4. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment) 5. Malignancy other than the condition being treated or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence 6. Use of any investigational drug within 30 days prior to screening 7. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results 8. Uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Maximum tolerated dose (MTD) of the combination of sunitinib and cyclophosphamide and response rate (complete and partial response);Main Objective: Maximum tolerated dose (MTD) of the combination of sunitinib and cyclophosphamide and response rate (complete and partial response); Secondary Objective: 1) Toxicity of treatment 2) Progression-free and overall survival 3) Correlation between biological markers in original nephrectomy specimen (if available) or on-study biopsies with clinical outcome and serum biomarkers including circulating tumour cells 4) CT and PET assessment of tumour blood flow / disease activity 5) Recrudescence of symptoms/signs during the 2 week interval off sunitinib | — |
Countries
United Kingdom
Outcome results
None listed