Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of a First-line Treatment With VEGF Inhibitor
Overview
- Phase
- Phase 4
- Intervention
- Everolimus
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Mario Negri Institute for Pharmacological Research
- Enrollment
- 31
- Locations
- 8
- Primary Endpoint
- predictive factors identification
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)
Detailed Description
Predictive factors to be considered are: histology, Heng risk group, Eastern Cooperative Oncology Group-performance status (ECOG-PS), site of metastases, glycemia and cholesterolemia. The data collected in this "real life" population could contribute to identify clinical factors that predict favourable outcomes in patients treated with everolimus after failure or a a first-line treatment with a VEGF inhibitor.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell);
- •ECOG-PS 0-1-2;
- •With target and/or non-target lesions according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1;
- •Following failure of a previous treatment with VEGF-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
- •For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
- •Willing and able to comply with follow-up and all other protocol requirements and able to commence treatment within 21 days;
- •Written informed consent obtained before any screening procedure and according to local guidelines.
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
- •Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
- •Other malignancy diagnosed within the last 5 years, except the following, if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer;
- •Treatment with an investigational agent in the past 4 weeks;
- •Clinically relevant human immunodeficiency virus, hepatitis B virus, hepatitis C virus infection;
- •Non adequate liver function as shown by:
- •serum or plasma ALT and AST \>3.0x upper limit of normal (ULN) \>5 if hepatic metastases are present;
- •Serum or plasma total bilirubin: \>1.5xULN (excepted for patients with Gilbert's syndrome);
- •Non adequate renal function as shown by serum creatinine \>2.5xULN;
Arms & Interventions
Everolimus
All patients will receive everolimus 10 mg orally per day. Treatment will continue until progression, unacceptable toxicity, patient refusal or medical decision
Intervention: Everolimus
Outcomes
Primary Outcomes
predictive factors identification
Time Frame: 36 months
To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC). A favourable outcome is being alive and on treatment without both disease progression (according to RECIST 1.1) and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D VAS).
Secondary Outcomes
- Progression free survival (PFS) of everolimus as second line treatment(36 months)
- health related quality of life (HRQoL)(36 months)
- drug-related toxicity(36 months)
- compliance(36 months)