A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Renal Cell Cancer Clinical Trial

Official title:

A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738530
• Other study ID #: BO17705
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2008
• Last updated: February 1, 2016
• Start date: June 2004
• Est. completion date: August 2011

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in patients with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients;

• >=18 years of age;

• metastatic renal cell cancer (clear cell type);

• nephrectomy;

• absence of proteinuria.

Exclusion Criteria:

• prior systemic treatment for metastatic renal cell cancer;

• major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;

• presence of brain metastases;

• ongoing need for full dose anticoagulants;

• uncontrolled hypertension;

• clinically significant cardiovascular disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

Intervention

Drug:
• bevacizumab [Avastin]
10 mg/kg iv every 2 weeks
• interferon alfa 2a [Roferon]
9 MIU SC 3x/week
• placebo
iv every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival.\n		Week 52	No
Secondary	Efficacy: Progression-free survival, time to disease progression, time to treatment failure, objective response rates. Safety: Hematology, serum chemistry, urinalysis, and adverse events.\n		Throughout study	No