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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: August 19, 2008
Last updated: October 6, 2014
Last verified: October 2014

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 t ime of study treatment is 1-2 years, and the target sample size is 500+ individu als.

Condition Intervention Phase
Renal Cell Cancer
Drug: bevacizumab [Avastin]
Drug: interferon alfa 2a [Roferon]
Drug: placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival.\n [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Progression-free survival, time to disease progression, time to treatment failure, objective response rates. Safety: Hematology, serum chemistry, urinalysis, and adverse events.\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 649
Study Start Date: June 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10 mg/kg iv every 2 weeks
Drug: interferon alfa 2a [Roferon]
9 MIU SC 3x/week
Placebo Comparator: 2 Drug: interferon alfa 2a [Roferon]
9 MIU SC 3x/week
Drug: placebo
iv every 2 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00738530

  Show 104 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00738530     History of Changes
Other Study ID Numbers: BO17705
Study First Received: August 19, 2008
Last Updated: October 6, 2014
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 20, 2014