An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 9, 2011
Last updated: April 7, 2014
Last verified: April 2014

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient for up to 4 years.

Renal Cell Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival: time from first drug administration to documented disease progression or death of any cause [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall response rate: complete response or partial response according to RECIST criteria [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with advanced and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a


Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Advanced and/or metastatic renal cell carcinoma
  • Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
  • At least one measurable and non-measurable lesion according to RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow, renal and liver function

Exclusion Criteria:

  • Contraindications to Avastin and/or interferon alpha-2a as per local label
  Contacts and Locations
Please refer to this study by its identifier: NCT01351571

Aurangabad, India, 35
Delhi, India, 110085
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01351571     History of Changes
Other Study ID Numbers: ML25251
Study First Received: May 9, 2011
Last Updated: April 7, 2014
Health Authority: India: Directorate General of Health Services - Drugs Controller General

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
Interferon Alfa-2a
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 processed this record on April 17, 2014