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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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00738530
First received: August 19, 2008
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

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

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

  Show 105 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00738530     History of Changes
Other Study ID Numbers: BO17705
Study First Received: August 19, 2008
Last Updated: November 15, 2011
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
 Interferons
Bevacizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013