A randomized, open label, multicenter phase II study of first line therapy with Sorafenib in association with Interleukin 2 versus Sorafenib alone in patients with unresectable and/or metastatic renal cell carcinoma (RCC) - ROSORC

• Conditions: ADVANCED RENAL CELL CANCER; MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinoma

• Registration Number: EUCTR2006-003137-32-IT
• Lead Sponsor: I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Signed written informed consent (approved by institutional review board / independent ethics committee)

2.Patient must be willing and able to comply with the protocol

3.Age >= 18 years

4.Patients with cito-hystological diagnosis of renal cell carcinoma (RCC)

5.If the initial diagnosis of RCC is dated more than two years ago,cito- histological confirmation of renal cell carcinoma origin of the current lesions is mandatory

6.Fertile women (<2 years after last menstruation) and men of childbearing potential must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilisation)

7.Measurable disease (as per RECIST criteria)

8.Karnofsky performance status >/= 60%

9.Life expectancy greater than 3 months

10.The required values at baseline are as follows:

Absolute neutrophil count >1.5 x 109 /L, Platelet count > 100 x 109 /L, Haemoglobin > 9g/dl, total bilirubin < 1.5 upper limit of normal (ULN); AST, ALT<2.5 ULN in patients without liver metastases, <5 ULN in patients with liver metastases; serum creatinine < 2.0 mg/dl, amylase and lipase <1.5 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

1.Prior medical treatment for metastatic RCC (are allowed adjuvant or neo-adjuvant treatment but stopped almost from six months)

2.Major surgical procedure within 28 days prior to study treatment start

3.Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patients must undergo a MRI or CT scan of the brain within 28 days prior to randomisation

4.Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, meningiomas)

5.Clinically significant cardiovascular disease, for example cerebrovascular accidents (<6 months), myocardial infarction (<6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication

6.Recent (within the 30 days prior to randomisation) treatment with another investigational drug or participation in another investigational study

7.Chronic treatment with corticosteroids (dose >10 mg/day methylprednisolone equivalent) excluding inhaled steroids.

8.History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications

9.Prior isotope treatment

10.PT or INR and PTT <1.5 times the Upper Normal Limit of the institution (patient who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists).

For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care

11.Previous or concomitant radiotherapy in the site parameter of disease

12.Previous radiotherapy or other locoregional antitumoral treatment performed within 21 days before the study recruitment

13.Uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic) while receiving chronic medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival;Secondary Objective: 1. To determine the overall survival, objective response rates of Sorafenib and Interleukin 2 as compared with Sorafenib alone<br><br>2. To characterize the safety profile of the combination therapy versus Sorafenib alone;Primary end point(s): To evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival