A randomised, double-blind phase III study to evaluate the efficacy and safety of bevacizumab in combination with interferon alfa-2a (Roferon) versus interferon alfa-2a and placebo as first line treatment administered to nephrectomised patients with metastatic clear cell renal cell carcinoma

Conditions: renal cell carcinoma
MedDRA version: 14.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2004-000282-35-IT

Lead Sponsor: ROCHE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 638

Inclusion Criteria

Patients in study BO17705 with metastatic clear cell renal cancer who have had nephrectomy, who participate in the BO17705 Population PK subset, and who are on stable bevacizumab (or placebo) 10 (or 5) mg/kg plus stable interferon alpha-2a treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 systemic treatment for metastatic RCC disease (including neo-adjuvant therapy) 2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study 3. Serious non-healing wound, ulcer or bone fracture 4. Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patients must undergo an MRI or CT scan of the brain (with contrast if possible) within 28 days prior to randomization. 5. Seizure(s) not controlled with standard medical therapy 6. Other malignancies within the last 5 years prior to randomisation (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix) 7. Evidence of bleeding diathesis or coagulopathy 8. Ongoing or recent (< 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day) 9. Uncontrolled hypertension (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic) while receiving chronic medication 10. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents and myocardial infarction ( both ≤ 6 months before randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication 11. Recent (< 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study 12. Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent), excluding inhaled steroids 13. History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ? To determine the efficacy of the combination of bevacizumab and Roferon as compared with Roferon and placebo in patients with metastatic RCC, based on overall survival.;Secondary Objective: ? To determine the progression free survival, time to disease progression, time to treatment failure and objective response rates of bevacizumab and Roferon as compared with Roferon and placebo. ? To characterize the safety profile of the combination of bevacizumab and Roferon as compared with Roferon and placebo. ? To determine the population pharmacokinetics and to explore the pharmacodynamics of bevacizumab and the potential existence of anti-bevacizumab antibody;Primary end point(s): Non disponibile

Secondary Outcome Measures

Name	Time	Method

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